A QUANTUM LEAP FOR INVESTMENT IN PATIENT SAFETY:
A LEGAL & MORAL DUTY
A PAPER BY SIMON JOHN AND MICHAEL POWERS QC
SEPTEMBER 2011
©
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1. CONTENTS
CHAPTER/
TITLE OF THE CHAPTER/ Paragraph
Para No.
2.
EXECUTIVE SUMMARY
3.
INTRODUCTION
4.
THE EXTENT OF INJURY TO PATIENTS IN
ENGLISH NHS HOSPITALS
4.1
The English benchmark epidemiological
evidence
4.2
Outcomes of medical adverse events
4.3
Parliamentary Reliance
4.4
Other medical adverse events data
4.5
These fatalities in context
4.6
Studies by Specialty
4.6.1
Hospital Acquired Infections
4.6.2
Venous Thromboembolisms
4.6.3
Surgery
4.6.4
Care for the Elderly
4.6.5
Adverse Drug Events
4.6.6
Intensive Care
4.6.7
Adverse Events in emergency departments
4.6.8
Obstetrics
4.7
4.8
Safety Ratings by Dr Foster
4.9
4.10
International comparative data for adverse events
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5.1
5.2
5.3
5.4
5.5
5.6
5.7
6
The number and cost of claims by specialty
Comment
THE CAUSES OF MEDICAL ADVERSE
EVENTS
Systemic causes
Bupivacaine and vincristine
The Health Select Committee’s (“HSC”) view
Detailed investigation rare
International Classification of Diseases Y40-Y84
Failure to Learn from mistakes
Comment
THE TOLERABILITY OF RISK
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No.
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6.1
6.2
6.3
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7.1
7.1.1-5
7.2
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
7.3.8
7.4
7.4.1
7.4.2
7.4.3
7.5
8.
8.1
8.2
8.3
8.4
8.5
9.
9.1
9.2
9.3
Introduction
Risk in Industry
The tolerable risk of death to a patient by a
medical adverse event
THE COST OF MEDICAL ADVERSE
EVENTS
The Distribution of the Cost of medical adverse
events
Distribution of costs
The cost of medical adverse events to Clinicians
The cost of Medical adverse events to the NHS
The cost of Adverse Drug-Related Events
(ADEs)
The cost of adverse Venous Thromboembolisms
(“VTE”s)
The cost of Hospital Readmissions to the NHS
The cost of hospital acquired infections (HAIs)
The cost of additional bed days brought about by
medical adverse events
Lifelong medical treatment of permanent injuries
Litigation Claims
Total of cost to the NHS
The Cost of medical adverse events to Society
“The Value of Prevention"
The cost of medical adverse events to our benefit
system
The cost to patients
Conclusion and total cost of medical adverse
events
WORLD ATTENTION TO MEDICAL
ADVERSE EVENTS,
The patient safety movement
The WHO’s World Alliance for Patient Safety
The Institute for Healthcare Improvement (IHI )
“Building A Culture Of Patient Safety” Report
Of The Eire Commission 2008
The National Practitioner Data Bank (NPDB)
PATIENT SAFETY IN ENGLAND
Introduction
The Quality Care Commission (CQC)
The National Patient Safety Agency (NPSA)
Never Events
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9.4
9.5
9.6
9.7
9.8
9.9
9.10
9.11
9.12
9.13
9.14
10.
10.1
10.2
10.3
10.4
10.5
10.6
10.7
10.8
10.9
10.10
10.11
10.12
10.13
Serious Incidents (SIs)
The NHS Institute for Innovation and
Improvement (“NHSI”)
The Patient Safety First Campaign 2008 -10
The UK Health Foundation (UKHF)
Clinical human factors group (CHFG)
The General Medical Council
The NHS Ombudsman
Monitor
The NHS Commissioning Board (NHSCB)
The Patient Safety All Party Parliamentary Group
(“PSAPPG”)
Confused, Ineffective Governance
THE HSC REPORT ON PATIENT SAFETY
Introduction – Evidence
From a Memorandum by the Royal College of
Opthalmologists.
From a Memorandum by the Health Foundation
From a memorandum by The Clinical Human
Factors Group
From a Memorandum by Guy Hirst and Trevor
Dale that echoed the last observations
From a Memorandum by the Health and Safety
Executive (HSE)
From a Memorandum by the Medical Protection
Society
From a Memorandum by the Confidential
Enquiry into Maternal and Child Health
Memorandum by the Patient Liaison Group:
Royal College of Surgeons England
Memorandum by the Quality, Reliability, Safety
and Teamwork Unit, Oxford University
(QRSTU)
From a Memorandum by the National Patient
Safety Agency (NPSA)
From a Memorandum by the Medical Defence
Union
From a Memorandum by the Royal College of
Nursing
From a Memorandum by the Royal College of
Midwives
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10.14
10.16
10.17
11.
11.1
11.2
11.3
11.4
11.5
11.6
12.
12.1
12.2
12.2.1
12.2.2
12.2.3
12.2.4
12.2.5
12.2.6
12.2.7
12.2.8
12.2.9
12.3
12.4
12.4.1
12.4.2
12.4.3
12.5
13.
From a Memorandum by AvMA
From a Memorandum by the Royal College of
Pathologists
From a Memorandum by the Council for
Healthcare Regulatory Excellence
From a Memorandum by the NHS Confederation
THE PSYCHOLOGICAL OR HUMAN
FACTORS PERSPECTIVE
Introduction
Mid Staffs
The HSC’s Patient Safety Report Conclusions
The academic view
Surgical Safety Checklist
Conclusion
THE CASE FOR RADICAL REFORM
Introduction
Can the present regime of regulation be relied on
to resolve this crisis alone?
Learning from mistakes
Should we employ doctors who are unable to
speak English to work in the UK?
Revalidation
Duty of Candour – disclosure to patients when
things go wrong
The mandated VTE risk assessment data
collection
The Surgical Safety Checklist
Recognising the value of NHS complaints
information
Putting Patient Safety at the top of meeting
agenda
Summing up
Is there a duty to make a greatly enhanced effort?
Is there is a reasonable prospect of success?
Progress
Government power to influence behaviour
Prospects of success
Recommendations
THE PROPOSAL - A MEDICAL ACCIDENTS
INVESTIGATION AUTHORITY
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APPENDIX EXECUTIVE SUMMARY TO THE 2002
1
PAPER “NHS HOSPITAL ACCIDENTS AND
OTHER ACCIDENTS COMPARED”
EXTRACTS FROM THE HOUSE OF
COMMONS HEALTH COMMITTEE REPORT
APPENDIX ON PATIENT SAFETY (PUBLISHED JUNE
2
2009)
A note about the authors
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2. EXECUTIVE SUMMARY
“We look for medicine to be an orderly field of knowledge and
procedure. But it is not. It is an imperfect science, an enterprise
of constantly changing knowledge, uncertain information, fallible
individuals, and at the same time lives on the line.”
Atul Gawande MD, MPH, Complications: A Surgeon’s Notes on an
Imperfect Science (2002)
According to the NHS’s own figures there are nearly 1 million NHS
hospital inpatient accidents (“medical adverse events”) every year in
English NHS hospitals. These result in about 72,000 deaths each year
and 211,000 people moderately or severely injured.
The same figures indicate an adverse incident rate of 11.7% (about 1 in 9)
of all patients admitted to hospital. The Department of Health (DOH)
states this rate is similar to other European countries.
The rate of medical adverse events deaths (those not caused by the
underlying medical condition) is 1 in 240 hospital admissions. This figure
compares in scale to the 1 death in 300 patients going into hospitals in the
developed world used by the DoH in “Good doctors, safer patients”.
The actual risk of death due to a medical adverse event on being admitted
to an NHS hospital is 40 times as great as that considered acceptable by
HSE as the upper limit value for third parties visiting high risk premises:
1 death in 10,000 per year.
Annual mortality associated with medical adverse events is
approximately the same as all female cancer deaths for 2008 (75,011).
The annual number of UK accidental fatalities from medical adverse
events exceeds by more than twenty times the combined number of
fatalities from other high risk activities such as marine activity, driving on
the roads, flying in aircraft, train travel and working in industry.
5,000 deaths may occur each year as a direct result of contracting an
infection whilst in hospital.
Venous Thromboembolisms (clots of blood in a vein) could account for
25,000 preventable deaths each year.
In one study readmission to hospital was considered to be related to
medication for 38% of patients and to be preventable for 25% of these.
7
About 175 babies are born every year with Cerebral Palsy that is
avoidable. Nine out of ten mothers who died from high blood pressure in
pregnancy between 2006 and 2008 had sub-standard care.
None of these figures include adverse events in A&E, following
outpatient appointments, primary care, private hospitals, or parts of the
UK other than England.
Dr Foster Intelligence (launched in part by the NHS Information Centre)
produced a 2009 report “How Safe is Your Hospital” all about patient
safety. All English NHS hospital trusts were given a safety rating out of
100. 10% of trusts scored 90 or more. 77% of trusts scored less than 75.
47% of trusts scored less than 50.
A tiny percentage of the 72,000 annual medical adverse event deaths
result in an inquiry let alone an inquest; especially the elderly - they slip
away unnoticed.
If we knew and learnt from reporting and investigating all medical
adverse events, thereby what had been their root causes, it would be much
easier to avoid them in future. Although this principle has been well
established in life generally and more recently in medicine particular it
appears we may be some way from achieving that art.
The annual cost of medical adverse events to the NHS alone is high – at
least:
Adverse Drug Events (wrong drug or dose) cost £ 466M
Hospital Readmissions due to errors cost
1,500M
Hospital Acquired Infections cost
Venous thromboembolism costs
1,000M
640M
Long term treatment of the 211,000 people
moderately or severely injured costs
2,480M
Claims (including costs) for clinical negligence
1,005M
Total £7.05Bn per annum
Using a well tried government formula "the Value of Prevention" (used
by the Department of Transport (DfT) and the NHS itself for road and
other accidents) we find that the indicative annual value for society of
preventing the “avoidable” medical adverse events is an additional
24.8Bn. On the same basis, the “human cost" to the patients affected is
£30Bn (£30,000M) p.a.
8
There is another way of approaching the annual cost to society of medical
adverse events. We go through the exercise as a cross check to the figure
produced by the DfT’s value of prevention method.
Less than ½ of 1% of medical adverse event victims make a claim that is
paid out. Those who do have a judge (or someone estimating what a
judge would) decide, first that they were preventable and then what has
been the cost of the event to them. That net figure amounted in 2010/11
to £764M.
No-one calculates the cost to society of medical adverse events for the
99.5% who do not recover compensation. But someone pays (in the sense
of providing care and substituting wages) and it is usually the taxpayer in
terms of benefits payable and services provided by the welfare state
during the period (short or long) that the former patients are incapacitated
and suffers as a result of the medical adverse event.
This approach to valuing the annual cost of medical adverse events to
society, produces a figure of a little over £38Bn, rather than £24.8 Billion.
A similar calculation finds that a figure of over £37Bn represents the cost
of medical adverse events left in the hands of patients personally.
Between £31.85Bn per annum and £44.45Bn per annum is the overall
indicative cost to The Exchequer (including the NHS and for
compensated and uncompensated patients) of the preventable medical
adverse events to inpatients in English NHS hospitals alone.
A further £37Bn per annum may be seen as left in the hands of that
overwhelming majority of victims of medical adverse events who do not
claim.
The NHS complaints statistics show an increase of 13.4% in complaints
between 2008-09 and 2009-10. The recently published figures for 201011 do not show much decrease from this record high.
Despite Sir Ian Kennedy’s repeated urging, Lord Darzi’s clarion call and
two years of exhortation and coaxing by the Patient Safety First
Campaign and with the din of Mid-Staffs still ringing in their ears, nearly
40% of trusts’ boards could not be bothered, even a decade later, to put
patient safety at the top of their agenda.
If only a small minority of healthcare organisations are not safe that still
creates a lot of carnage. Other industries have grasped this message. If
only 0.1% of flights (1 in 1,000) crashed, that would still kill a lot of
9
people. In fact the odds of being killed on a single airline flight with one
of the best 25 airlines, with the best accident rates, are approximately
0.00001%.
This compares with the risk of death of about 0.25% due to a medical
adverse event on being admitted to an NHS hospital.
Notwithstanding these shocking figures it must be remembered that the
vast majority of NHS staff are highly skilled, dedicated and work very
hard.
Most errors are thought to be systemic, due to a weak system. [It]
“should be possible to reduce [substandard care through] educational
efforts and increased awareness of risk factors.”
If most medical adverse events are the result of poor systems and training
and can be mitigated by better ones, that would be a start.
Like other accidents at work, they can be largely prevented by adequate
investment in safety. The safety outcome is obviously related to the
adequacy of investment in safety.
The future of the National Patient Safety Agency (NPSA) functions in a
cost cutting environment appears to be in grave doubt. 80% of the NPSA
staff have left and will not be moving to successor organisations.
No Patient Safety Alerts (the safety advice arising from hospital incident
reports to NPSA) have been issued by the NPSA for some time.
It is envisioned by civil servants that only a small fraction of the
functions of The NPSA’s patient safety division are to be assimilated
within the new NHS Commissioning Board.
The problem with the NPSA was that it had no teeth. Its lack of teeth
resulted in its failure to collect from practitioners more than a fraction of
the medical adverse events occurring and continued failure to achieve
compliance with the patient safety alerts from trusts.
In its new guise within the NHS Commissioning Board (NHCB) it will be
a very small toothless fish in a much bigger pond concerned largely with
negotiating with trusts as providers. The NHCB has not yet been created
and when it is will take time to find its feet even in its principal role.
The notion of a body concerned largely with General Practitioners
reforming anytime soon, the technical or other professional failures of
their hospital acute care colleagues is frankly absurd.
10
The Surgical Safety Checklist is a metaphor for much that is wrong about
patient safety provision. Merely with the use of a checklist, surgical
complications were reduced by more than one-third and deaths reduced
by almost half (from 1.5 per cent to 0.8 per cent).
Pilots around the world have been using checklists since 1937 after a fatal
air crash. One has to ask why did not surgeons or their physician
colleagues doctors think of this, decades ago.
However it is its reception among the NHS surgical community that
compounds the decades of delay. Its reception has not reassured us that
all trusts and surgeons put patient safety first. The NPSA in February
2009 urged all trusts to adopt the Checklist praising its proven patient
safety record. 6 months later, only 20% of trusts had actually launched
the programme in all theatres. Only 35% of trusts were using the 3 phases
of the checklist.
Nearly two and a half years after the checklist implementation, at least
one third of acute hospital trusts failed to respond to NHS questions about
its use. One can only speculate what their response has been.
Of those that did respond 27% still lacked full compliance, a widespread
73% of Trusts citing surgeons’ failure to engage with the checklist
(“some teams are pretty unenthusiastic – mainly led by indifferent /
hostile surgeons”).
Similar (although less marked) failures and lack of enthusiasm to save
lives are found in NHS trusts response to the prioritised and compulsory
campaign to reduce the 25,000 annual deaths from blood clots.
Likewise a significant minority of NHS trusts (20%) could not be
persuaded to comply with 5 or more patient safety alerts, most of those
being issued by the NPSA years previously.
At the regulatory level one finds a similar level of failure. In their
evidence to the HSC referred to below The Clinical Human Factors
Group, the Health and Safety Executive, The Medical Protection Society,
and the Quality, Reliability, Safety and Teamwork Unit, Oxford
University, variously criticized existing clinical governance including a
comment that governance structures were largely ineffective.
After many years of urging by Parliament there is no effective system to
learn from NHS patients’ complaints. This is despite a 13.4% rise to over
100,000 written complaints in the year to April 2010. The same lack of
11
systematic learning from medical mistakes applies to litigation claims,
coroners inquests, HSE and police enquiries.
Doctors have no legal duty to give the parents of a child who died as a
result of their negligence a truthful account of the circumstances of the
death, or even to refrain from deliberately falsifying records.
We have to reluctantly accept the Shipman Inquiry was told “There are
poorly performing doctors out there who are harming patients."
Estimates as to the number of these doctors ranged between 3 and 10 per
cent of doctors. Nonetheless despite the recommendation of the Shipman
Inquiry more than 8 years ago, the revalidation of doctors has still not
been rolled out.
Medics are still allowed to work in England even if they speak little
English, despite the death of a pensioner who died after being given up to
20 times the recommended dose of a drug when he was treated by Dr
Ubani working his first shift in Britain.
The GMC has recently announced it is planning a basic induction
programme for all foreign doctors to help them understand how
healthcare is practised in the UK. Whilst this is welcome, one wonders
why the idea took so long to strike them given that approaching 40% of
UK doctors are trained abroad.
What is of even greater concern is the adequacy of the patient safety
budget and thus the extent of the resulting safety outcomes. The NPSA is
only one of several agencies and initiatives but it is the lead body
involved.
Comparisons can be made between government sponsored industries’
investment in safety systems per prospective life to be saved, i.e. how
much is spent to save a life from an obvious risk.
The DfT decided to spend £5M per life prospectively saved on the
cheaper Train Warning Protection System to avoid tragedies like
Paddington. Unfortunately, the budget of the NPSA equated to a mere
£347 per prospective life to be saved; but a tiny fraction (almost 1/15,000th)
of the equivalent railway spend.
Discrete investment in patient safety is grossly disproportionately low to
the cost of medical adverse events. The law requires the government as
the holder of the duty to provide healthcare to invest not merely the same
as the value of the risk, but grossly disproportionately more than the risk.
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The extent of the loss of life – known for a decade or more has not been
enough to break the complacency in either government or the health
sector. As the Select Health Committee put it a “culture persists in which
various types of harm to patients are seen as inevitable”. If the toll of
death and terrible injury is not enough the total cost to society of medical
adverse events is totally unaffordable.
The DoH, the health regulators, the health sector, whilst scoring high on
general medical advances, have failed us all on patient safety. They have
lost the right to maintain the monopoly of solving the dire problem of the
lack of patient safety.
The key to improving safety is the proper, effective and objective
investigation of accidents which cause injury and death. Surprisingly,
despite the NPSA’s creation a decade ago, no such system exists in the
NHS.
The AAIB and the MAIB have been instrumental in transforming the
standards of safety in air and marine operating environments respectively
and they are now widely regarded as benchmark organisations in safety
investigations and have been widely copied by other countries.
There should be a Medical Accidents Investigation Authority (MAIA),
set up to operate along similar lines in the United Kingdom.
This Authority would be completely independent of the NHS, although
ultimately responsible to the Secretary of State and it should have full
powers to investigate the causal and circumstantial factors associated
with fatal and serious medical incidents, publish reports and make
recommendations.
The Medical Accidents Investigation Authority (MAIA) proposed would
provide an effective means of investigating the facts surrounding medical
accidents without the need for litigation or the attribution of blame or
providing evidence for criminal investigation and/or disciplinary action.
This model has proved successful with the AAIB and MAIB.
Effective, independent investigation provides the key to ensuring that
lessons from medical accidents really are learned. All involved in patient
safety should welcome such an authority: it is essential to create
consistency of high standards of safety and improve morale in the NHS.
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3. INTRODUCTION
As lawyers specialising in representing those injured by mistakes in
hospitals, it is impossible not to be personally affected by the tragedy one
sees.
Consequently, rather like the safety officer in industry or the doctor on
the battlefield, we are eager to reduce medical adverse events and their
financial and social consequences by improving safety.
With our colleagues we spend much time discussing ways of achieving
this important objective. It is frustrating to see how rarely lessons are
learned. Sadly systems are not changed and the same mistakes are seen
over and over again.
As lawyers we have a great deal of sympathy with doctors and healthcare
workers who work in complex disciplines where error remains systemic.
A decade ago it was reasonable to say that the subject of accidents in
hospitals was a very complex one and is only gradually being understood.
The complexity has not changed but much research has been performed.
There is now a significant body of work by Inquiries (public and
otherwise) into episodes such as Shipman, Mid Staffs, Bristol and others.
The Parliamentary Health Ombudsman and the House of Commons
Health Select Committee have all spoken out about the lack of patient
safety in different spheres and made many unimplemented
recommendations.
There has been isolated reporting of these scandals but there doesn’t
appear to be much general awareness of the extent and cost of the
problem (within or without the NHS as a whole).
One of the reasons for a slightly increased interest and consequent
understanding may be the financial pressure which has recently been
brought to bear by the continued rise in annual compensation payable and
complaints made to the NHS over the last decade or more. However the
message has largely gone unheeded. There is no sense of a chronic health
crisis that must be conquered in the shortest time possible.
This paper looks at medical accidents in a wider context than other recent
papers and attempts to draw some conclusions, not only about the real
14
level and cost of hospital accidents, but the value of preventing them and
the need for much greater investment in safety in hospitals.
It is delivered in the hope of informing policy makers and the community
at large of the extent and cost of medical adverse events.
It is delivered in sorrow rather than anger.
15
4. THE EXTENT OF INJURY TO PATIENTS IN ENGLISH NHS
HOSPITALS
4.1 The English benchmark epidemiological evidence
The paper “NHS Hospital Accidents And Other Accidents Compared …
The Cost Of Accidents, The Value Of Their Prevention, And Investment
In Hospital Safety” published in 2002 (“the 2002 predecessor paper”) was
to a large extent provoked by and began with a reference to the Vincent
Study1describing the incidence of such accidents. Although one saw a
number of early papers challenging its extraordinary findings, ten years
later, the Vincent Study has been long accepted as providing the
benchmark data on the subject of “medical adverse events”2.
Thus The Department of Health’s National Patient Safety Agency
(NPSA) in “Seven Steps to Patient Safety” in 2004 cited the Vincent
Study:
“On the best available data in England, extrapolating from a small
study in two acute care trusts based in London, it is estimated that
around 10% of patients (900,000 using admission rates for 2002/3)
admitted to NHS hospitals have experienced a patient safety
incident, and that up to half of these incidents could have been
prevented. This study also estimated that 72,000 of these incidents
may contribute to the death of patients, although it is unclear what
proportion of this number would die as a direct result of the
incident”
It is worth pausing to comment on the word “contribute” as used here. A
contribution may be regarded as one that is material or significant.
The NPSA in using the term “around 10%” was speaking in broad terms.
The Vincent Study actually found that there was a medical adverse event
rate of 11.7% for all patients admitted to the hospital during the study
period. The Study describes and references the comparable rates found in
other countries in particular 3.7% in the US (from three states' studies)
and 16.6% in Australia. We will return to the comparators.
One finds in even the DOH literature both 11.7% and 10.8% quoted for
the Vincent Study. This is because Vincent found a significant number of
1 "Adverse events in British hospitals : preliminary retrospective record review" C. Vincent, G Neale and M Woloshynowych –
British Medical Journal Volume 322, 3 March 2001, at pages 517 – 519.
2 unintended injuries caused by medical mismanagement rather than the disease process.
16
patients with multiple adverse events. Therefore 10.8% of patients
experienced a medical adverse event, with an overall rate of 11.7%
allowing for more than one medical adverse event in some patients.
4.2 Outcomes of medical adverse events
Of course death is not the only outcome of such events. Vincent found
that annual injuries affected a number approaching one million people:
844,560.
As regards the extent of these injuries, the Vincent Study found that 72%
recovered within one month, 21% (177,240 patients) suffered an injury or
complication which resulted in moderate disability, and 7% (59,080
patients) suffered an injury leading to permanent disability.
Of the injured, the latter two categories cause most concern: the 236,320
patients who suffer a disability. For the purpose of this paper we propose
to call them the seriously injured.
Vincent found that 34% (308,320) of medical adverse events resulted in
either death or disability which ranged from moderate to severe.
It is estimated that for one patient in every 300 entering hospitals in the
developed world, medical error results in, or hastens, death.
This statement is in the DoH publication “Good doctors, safer patients”3
written by Sir Liam Donaldson the then Chief Medical Officer (“CMO”)
for England in July 2006.The footnote reads
“Based on calculations by Dr Lucian Leape, Harvard School of
Public Health, United States of America (unpublished, used with
permission).”
It is self evident but worth underscoring that these alarming figures relate
only to English NHS hospital inpatients; none of these figures includes:
o patients who experienced errors that had no adverse outcome,
o or patients who had an unexpectedly poor outcome or who
suffered injuries as a result of the disease process,
o patients who suffer adverse events in primary care,
o patients who suffer adverse events in private hospitals
o patients who suffer adverse events in any hospitals in parts of the
UK other than England.
3 Chapter 7 para 4
17
o patients who suffer medical adverse events in other hospital
settings such as A&E or after outpatient appointments.
4.3 Parliamentary Reliance
In case the DOH reliance on these figures is thought outdated or
erroneous for any reason it is worth looking to Parliament. The House of
Commons’ Health Select Committee (“HSC”) in Session 2008-09 took
evidence from Professor Thomson (a Professor of Epidemiology at
Newcastle University) for its Sixth Report on Patient Safety4.
Professor Thomson gave evidence that the best available data on the
overall extent of harm to NHS patients in England consist of
"hospital case note review studies, the studies that have looked at
medical records of patients", which "demonstrate that around 10%
of admissions to hospital suffer some form of harm". “These data
show that, in between a third and half of admissions associated
with harm, that harm was preventable.”
4.4 Other medical adverse event data
It is important to distinguish between these, now conventionally accepted
data, and the data assembled by the DoH from the self reporting forms
submitted by doctors and nurses to The National Patient Safety Agency
(“NPSA”).5 These data have been the subject of much controversy and
are generally accepted as representing a very significant degree of underreporting. For this reason such self reporting of adverse events became
compulsory in April 2010. However we have not seen evidence that the
level of reporting has improved even to approximate the conventional
data.
ICD 10 Classifications Y40-Y84 are generically described as
“Complications of medical and surgical care” but are not generally
completed by clinicians. According to the completed returns there were
only 40 deaths in London and 326 deaths in England from all these
classifications for 2009. More including the data can be found on this
issue in Paras 5.5 and 12.3. These figures are erroneous.
4 http://www.publications.parliament.uk/pa/cm200809/cmselect/cmhealth/151/15102.htm. This Report is referred to frequently
throughout this paper and in detail at Chapter 10. Some evidence to it is set out in Appendix 2.
5 Part of the NPSA’s Reporting and Learning System
18
4.5 These fatalities in context
Those figures are so great that it is difficult to take them in; to put them
into any sort of context.
Annual mortality associated with medical adverse events is
approximately the same as all female cancer deaths for 2008 (75,011)6; it
exceeds that from lung, breast, ovary and large bowel cancers combined
for both sexes.
The World Health Organisation (“WHO”) has produced a number of
“Patient Safety Facts” (PSFs). In PSF 9 the WHO states
“Industries with a perceived higher risk such as aviation and
nuclear plants have a much better safety record than health care.
There is a one in 1,000,000 chance of a traveller being harmed
while in an aircraft.”
he irony that deaths from medical adverse events are caused by people
whose vocation is to do their utmost to save lives, not end them. The UK
is not alone in having high rates of medical adverse events. Details of
international data are given at para 4.9 below.
Health is now regarded by some as an industry. Given the different
causation of most of the deaths compared above it may be instructive to
look at the numbers of fatalities from other high risk industries such as
aviation, motor (road traffic accidents) and other industries such as rail
transport, manufacture and construction.
Table 1 gives the data. It will be seen that the annual number of UK
accidental fatalities from medical adverse events exceeds by more than
twenty times the combined number of fatalities from other high risk
activities such as marine activity, driving on the roads, flying in aircraft,
train travel and working in industry.
Table 1 – annual UK accident fatalities from rail, aviation, all industry,
road traffic accidents and English NHS medical adverse events.
6 http://info.cancerresearchuk.org/prod_consump/groups/cr_common/@nre/@sta/documents/generalcontent/018070.pdf
19
Annual UK Fatalities
80000
70000
60000
50000
40000
30000
20000
10000
0
72000
18
34
595
Marine
Aviation
Industry
5
Rail
2538
Road
Traffic
MAE's
Key to Table 1:
Rail – this is an average figure rail for passenger fatalities for the 10 years to 2007. It
excludes the 56 people who died in London terrorist attacks in July 2005. (Source:
Transport-watch.co.uk).For the last four years there have been no passenger, workforce
or public fatalities in train accidents.
Marine fatalities [18] include UK personnel worldwide in the merchant navy, fisherman,
leisure and small craft and cruise ships for 2009.(Source: The Marine Accident
Investigation Branch)Aviation – the actual UK figure is believed to be zero for the past
many years in relation to aircraft carrying six passengers or more. The figure that is given
is the average annual figure for 1998-2007 in respect of the worldwide operation of public
and non-public, UK registered large and small conventional aeroplanes, helicopters,
airships, gliders, microlights, gyroplanes and balloons (Source: The CAA). The 2010
global figure for passenger airliners registered anywhere is 817.
Industry – All Industry (excluding medicine) includes all workplace accidents such as
manufacturing, construction, rail workers and agriculture etc. The majority of these
fatalities are not “accidents” at all but suicides on the railway.(Source: HSE & Risk
Assessment Data Directory).
Road traffic accidents - Count for 2008. In 2009 the figure fell (again) by 12.5% to 2,222
(Source: DfT) and yet again in 2010 by a further 16% to 1,857
MAEs - English NHS hospital medical adverse events based on the Vincent Study.
4.6 Studies by Specialty
The Vincent Study concluded that further studies should be performed. A
number of other papers have made similar recommendations but no such
work has been commissioned by the DoH.
20
However studies have been performed in the UK and elsewhere in the
world looking at adverse events in particular aspects or fields of medicine
and it is helpful to look at them to give further background and
understanding to the horrific figures for death and serious injuries from
medical adverse events to see how they might be constituted.
It is perhaps no surprise to see that that hospital acquired infections,
avoidable blood clots, surgery, treatment of the elderly, drug
administration, intensive care, emergency departments and obstetrics are
up there amongst the highest risk areas for patients.
4.6.1 Hospital Acquired Infections
In 2009 The National Audit Office (“NAO”) published the latest in a
series of reports on hospital acquired infections.7 Para. 2.31 of that report
states:
“Healthcare associated infections can compromise a patient’s
recovery; cause anxiety and discomfort; and can also lead to
permanent disability and, in some cases, death. In our 2004 report
we noted that national data on deaths due to healthcare associated
infections was poor, and that the only national estimates were
published by the Department in the ‘Cooke Report’ (1995). These
estimates suggested that as many as 5,000 deaths may occur each
year as a direct result of contracting an infection whilst in hospital,
with 15,000 deaths where infection was a contributory factor.”
4.6.2 Venous Thromboembolisms
In 2005 the HSC reported8 that Venous Thromboembolisms (clots of
blood in a vein) could account for 25,000 preventable deaths each year.
This figure was repeated and reinforced in a further paper “Venous
Thromboembolism Prevention A Patient Safety Priority”9 published in
June 2009 by The Kings Fund, DoH and The All-Party Parliamentary
Thrombosis Group (“APPTG”).
In the Foreword by Professor Sir Liam Donaldson Chief Medical Officer
and John Smith MP Chair of the APPTG it was observed:
7 NAO: Reducing Healthcare Associated Infections in Hospitals in England 12/6/9
8 House of Commons Health Select Committee Report on the Prevention of Venous Thromboembolism in Hospitalised Patients
http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/99/99.pdf
9 http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_101397.pdf
21
VTE prevention has too long been overlooked as a priority and
only now are we beginning to understand the challenge around
better VTE metrics and related health economics issues.
….The emerging picture of death and acute and chronic disability
(such as chronic venous insufficiency, venous leg ulcers and
pulmonary hypertension) leaves no room for complacency when
low-cost effective preventative treatments are available.
4.6.3 Surgery
So concerned was it at the lack of safety in the field of surgery that the
WHO has introduced a “Safe Surgery Saves Lives” program. The
program included the introduction of the “Surgical Safety Checklist.”
Between October 2007 and September 2008, doctors in eight hospitals in
eight cities (Toronto, Canada; New Delhi, India; Amman, Jordan;
Auckland, New Zealand; Manila, Philippines; Ifakara, Tanzania; London,
England; and Seattle, USA) representing a variety of economic
circumstances and diverse populations of patients, participated in a study
to test the efficacy of the program.
A paper resulted.10 Believing surgical complications are common and
often preventable, the authors
“hypothesised that a program to implement a 19-item surgical
safety checklist designed to improve team communication and
consistency of care would reduce complications and deaths
associated with surgery”.
Data was collected from nearly 4,000 episodes of consecutive adult
noncardiac surgery.
“The primary end point was the rate of complications, including
death, during hospitalisation within the first 30 days after the
operation. The study found that the rate of death was 1.5 per cent
before the checklist was introduced and declined to 0.8 per cent
afterward (p=0.003). Inpatient complications occurred in 11.0 per
cent of patients at baseline and in 7.0 per cent after introduction of
the checklist.”
10 Surgical safety checklist to reduce morbidity and mortality in a global population; A Haynes et al for the Safe Surgery Saves
Lives Study Group, The New England Journal of Medicine, January 14 2009; 360(5):491-499
22
A study conducted in the Netherlands and published on 10 November in
the New England Journal of Medicine (NEJM) confirms the earlier report
from the USA, that the use of a surgical safety checklist significantly
reduces surgical morbidity and mortality.
The Netherlands study, carried out from October 2007 to March 2009,
shows that with the use of a checklist, surgery complications were
reduced by more than one-third and deaths reduced by almost half (from
1.5 per cent to 0.8 per cent).
This massive reduction in deaths alone resulted from the use in theatre of
a short checklist before surgery commenced. This was a good idea. It’s
the sort of thing many people do (or wish they had) even for such a
simple exercise as leaving home to go on holiday.
Certainly pilots around the world have been using checklists since the
pilots of a B17 aircraft devised them at Langley Field, Virginia, in
August, 1937 after a fatal air crash.
“The pilots sat down and put their heads together. What was
needed was some way of making sure that everything was done;
that nothing was overlooked. What resulted was a pilot’s checklist.
Actually, four checklists were developed - takeoff, flight, before
landing, and after landing. The [B17] was …simply too complex
for any one man’s memory. These checklists for the pilot and copilot made sure that nothing was forgotten. With the checklists,
careful planning, and rigorous training, the twelve aircraft
managed to fly 1.8 million miles without a serious accident.“ 11
4.6.4 Care for the Elderly
Concern for the number (and cost) of cases where the elderly (patients
aged 75 and older) were readmitted within 28 days as an emergency,
prompted a study to identify communication gaps at hospital discharge.12
The study assessed the contribution of incomplete discharge information
to readmission and identified measures that might improve
11 How the Pilot's Checklist Came About by John Schamel
12 ‘Communication gaps and readmissions to hospital for patients aged 75 years and older: observational study’.EMA
Witherington, OM Pirzada, AJ Avery, Quality and Safety in Health Care, 2008; 17(1): 71-75
23
communication at hospital discharge. 62% either had no discharge letter
or returned before the letter was typed. Documentation of changes in
medication was incomplete on two-thirds of all discharge documents.
Readmission was considered to be related to medication for 38% of
patients and to be preventable for 25% of these. There were preventable
discharge communication gaps, including monitoring information, for
54% of these patients.
A damning report by Ann Abraham MP, Health Service Ombudsman for
England was published on 14 February 2011. It was called “Care and
compassion? Report of the Health Service Ombudsman on ten
investigations into NHS care of older people.”13 The BBC headline said
the report “beggars belief” That is no exaggeration.
In the Foreword the Ombudsman says to her fellow MPs:
“Sadly, of the ten people featured in this report, nine died during
the events described here, or soon afterwards.
…pause and reflect on my findings: that the reasonable expectation
that an older person or their family may have of dignified, painfree end of life care, in clean surroundings in hospital, is not being
fulfilled. Instead, these accounts present a picture of NHS
provision that is failing to respond to the needs of older people
with care and compassion and to provide even the most basic
standards of care”
The report’s Introduction makes difficult reading, especially for anyone
knocking on the door of old age. Here are some extracts from the report.
“This report tells the stories of ten people over the
age of 65, …. Loving partners, parents and grandparents…. people
with energy and vitality, active in their retirement and well known
and liked within their communities. Some were creative, while
others took pride in their appearance and in keeping fit. One
enjoyed literature and crosswords and another was writing a book.
What they have in common is their experience of suffering
unnecessary pain, indignity and distress while in the care of the
NHS.
13 http://www.ombudsman.org.uk/__data/assets/pdf_file/0016/7216/Care-and-Compassion-PHSO-0114web.pdf
24
Poor care or badly managed medication contributed to their
deteriorating health, as they were transformed from alert and able
individuals to people who were dehydrated, malnourished or
unable to communicate……
These are not exceptional or isolated cases.
Inattention to the suffering of older people is characteristic of the
stories in this report. Inadequate medication or pain relief that is
administered late or not at all, leaves patients needlessly distressed
and vulnerable.
The theme of poor communication and thoughtless action extends
to discharge arrangements, which can be shambolic and illprepared…..
It is incomprehensible that the Ombudsman needs to hold the NHS
to account for the most fundamental aspects of care: clean and
comfortable surroundings, assistance with eating if needed,
drinking water available and the ability to call someone who will
respond. Yet as the accounts in this report show, these most basic
of human needs are too often neglected….. Half the people
featured in this report did not consume adequate food or water
during their time in hospital…… Older people are left in soiled or
dirty clothes and are not washed or bathed.
An impetus towards real and urgent change, including listening to
older people, taking account of feedback from families and
learning from mistakes is needed. I have yet to see convincing
evidence of a widespread shift in attitude towards older people
across the NHS that will turn the commitments in the NHS
Constitution into tangible reality.
The NHS must close the gap between the promise of care and
compassion outlined in its Constitution and the injustice that many
older people experience.
In each of the accounts included here, a complaint was first made
to the NHS body or trust concerned. Not only did those who
complained to me experience the anguish of the situations
described, but throughout the NHS complaints process their
concerns were not satisfactorily addressed.”
25
Anyone who finds it difficult to accept that these are not isolated cases
should cross refer to the mention of the Francis Inquiry into Mid-Staffs
NHS Foundation Trust at Para. 11.2. Not in that mention is the following
extract from the written evidence of a former patient and witness to that
Inquiry:
“Malnutrition and starvation ……was one of the hazards of being
in geriatric wards at Stafford”
4.6.5 Adverse Drug Events
A study has been made in the US of preventable adverse drug events
(ADEs).14 In the study period, there were 4,031 admissions to the study
units, comprising 21,412 patient-days.
The study found 247 ADEs and 194 potential ADEs. Extrapolated, this
amounted to 1900 ADEs per hospital per year, with, for every 100
admissions, 6.5 ADEs and 5.5 potential ADEs. Of all ADEs, 1% were
fatal, 12% life-threatening, 30% serious and 57% significant.
The rate of ADEs was highest in medical intensive care units (19 per
1,000 patient-days) and relatively similar among surgical intensive care
and medical and surgical general care units (9 - 11 per 1,000 patientdays).
Seventy (28%) of 247 ADEs were preventable and 83 (43%) of 194
potential ADEs were intercepted before the drug was given. Errors
resulting in preventable ADEs occurred most often at the stages of
ordering (56%) and administration (34%); transcription and dispensing
errors were uncommon. Errors were more likely to be intercepted if they
occurred early in the process - 48% at the ordering stage but none at
administration of the drug.
At home a 2009 report by the National Patient Safety Agency (NPSA)
has revealed a rise in the number of medical negligence incidents
occurring from improper drug administration.
Figures from the new Safety in Doses study show that the number of
medication incidents reported in England and Wales increased in 2007 to
86,085.
14 DW Bates, DJ Cullen, N Laird et al (for the ADE Prevention Study Group). Incidence of adverse drug events and potential
adverse drug events. Implications for prevention. Journal of the American Medical Association 1995 274:29-34.
26
This is in comparison to the 64,678 incidents reported the previous year.
Moreover, 100 of the recorded incidents proved to have serious or fatal
health repercussions for the patients concerned, with mistakes in
administration and prescription accounting for the majority of cases.
The NPSA suggested that the figures demonstrated the improved nature
of the NHS's reporting infrastructures, stating that the figures would aid
medical practitioners in improving future health provision.
4.6.6 Intensive Care
There has been a study in the US of medical adverse events in critical
(“intensive”) care medicine.15 The one year study in a US university
(teaching) hospital concluded errors involving critically ill patients were
common and often potentially life-threatening. Although many types of
errors were identified, failure to carry out intended treatment correctly
was the leading category.
The paper reported 13.8% preventable medical adverse events per patient;
and 12.8% preventable medical adverse events per admission. They also
found almost twice as many serious errors (“near misses”) that did not
have an adverse consequence. Among adverse events, 13% were lifethreatening or fatal; and among serious errors, 11% were potentially lifethreatening. Most (61%) serious medical errors occurred during the
ordering or execution of treatments, especially medications. Performance
level failures were most commonly slips and lapses (53%), rather than
rule-based or knowledge-based mistakes.
Another study16, in Israel, was set in a Medical-surgical 6 bed ICU of a
university hospital.
During the 4 months of data collection, a total of 554 human errors were
reported by the medical staff. There was an average of 178 activities per
patient per day and an estimated number of 1.7 errors per patient per day.
For the ICU as a whole, a severe or potentially detrimental error occurred
on average twice a day.
15 Critical Care Medicine August 2005 - Volume 33 - Issue 8 - pp 1694-1700;The Critical Care Safety Study: The incidence and
nature of adverse events and serious medical errors in intensive care.
16 A look into the nature and causes of human errors in the intensive care unit: Donchin et al; Qual Saf Health Care
2003;12:143-147 doi:10.1136/qhc.12.2.143
27
This paper concluded that a significant number of dangerous human
errors occur in the ICU. Many of these errors could be attributed to
problems of communication between the physicians and nurses.
4.6.7 Adverse Events in emergency departments (EDs)
Although it is appropriate to give some basic information, about EDs
none of the deaths and injuries referred to in this paper include those for
EDs. They are clearly many, but we do not have a number. Critical
incidents in UK EDs have been investigated in a 12 months study in two
teaching hospitals and two district general hospitals in the north-west of
England.17 The rate of occurrence was found to range from 11.1 to 15.9
per 1,000 new patients.
The most common root causes underlying these critical incidents were
found to relate to organisational issues outside the EDs; internal
management issues; human errors relating to knowledge of task
verification and execution; and issues related to patient behaviours. In
contrast, technical root causes occurred infrequently. The report
concludes that there are significant differences, as well as common
themes, in the causes of these critical incidents between different EDs.
4.6.8 Obstetrics
Obstetrics is regarded by some as the most high risk field in medicine.
One thing is certain. Outcomes are amongst the worst, for the relatively
small number of mothers and their children affected by a medical adverse
event causing injury in this field.
Stillbirth, arm paralysis, and cerebral palsy (“CP”) in the baby and/or
death, brain injuries, uterine (resulting in hysterectomy) and genital
injuries, for the mother predominate in the medical adverse events at or
around birth.
CP is often a combination of cognitive brain damage and writhing or
postural paralysis. Although life expectancy is not good for sufferers of
CP, many today live well into middle life. As well as mothers, fathers and
the whole extended family are affected by CP.
There were 708,711 live births in the UK in 2008. The mean annual
prevalence rate for CP was 2.0 per 1000 live births for birth years 1986–
1996.18 It follows that there are about 1400 CP cases annually in the UK.
Of these CP births the generally accepted view of paediatric neurologists
17 ‘Incidence and causes of critical incidents in emergency departments: a comparison and root cause analysis’. M Thomas, K
Mackway-Jones. Emergency Medicine Journal, June 2008; pp1-7
18 UKCP: a collaborative network of cerebral palsy registers in the United Kingdom: Journal of Public Health | Vol. 28, No. 2,
pp. 148–156
28
is that about 12.5 % are causally related to preventable medical adverse
events.19
This equates to 175 new babies every year whose CP is avoidable.
Most avoidable CP is caused by fetal asphyxia. Asphyxia results from an
inadequate supply of oxygen to the foetus during labour and delivery.
New evidence suggests a stronger link between substandard care and
severe asphyxia (causing CP) than the 12.5% that had been generally
accepted. A new study from Sweden shows that infants of women who
received substandard care during labour had a three-fold increased risk of
asphyxia at birth after 5 minutes of age.20
The study is based on all (74,539) births in Stockholm County, Sweden,
between 2004 and 2006. The researchers found that there was
substandard care during labour in two thirds of infants born with signs of
asphyxia, and in one third of healthy infants.
The main reasons for substandard care were related to misinterpretation
of CTG (recording of fetal heartbeat and uterine contractions during
childbirth), not acting on an aBnormal CTG in a timely fashion, and
misuse of oxytocin (a birth stimulant). Lead study author, Dr Sophie
Berglund said:
" The main reasons for substandard care are factors that, in
theory, are possible to prevent, and in practice, should be possible
to reduce through educational efforts and increased awareness of
risk factors associated with risk of asphyxia."
But it is not merely the children who suffer.
Clear guidance is there for health professionals in the community and
hospitals on how to recognise and manage pre-eclampsia. Nonetheless
unborn longed for babies and mothers die needlessly.
In 2005 PRECOG guidelines21 were introduced nationally to assist
identifying pre-eclampsia – the most common medical complication of
pregnancy – in pregnant women.
Pre-eclampsia is the second most common cause of death in pregnancy
and responsible for 1000 fetal deaths a year. It causes a third of all serious
obstetric morbidity and is the leading known cause of stillbirths.
19 Volpe et al.
20 Berglund S, Pettersson H, Cnattingius S, Grunewald C. 'How often is a low Apgar score the result of substandard care during
labour?' BJOG; An International Journal of Obstetrics and Gynaecology, 21 April 2010, DOI: 10.1111/j.1471-0528.2010.0265.
21 Milne et al, BMJ 2005;330:576-580
29
In a rare move a dozen senior people including some of the most eminent
professors of obstetrics and fetal medicine in the UK wrote a letter to The
Times on 29th March 201122.
“The latest UK report into deaths in pregnancy is shocking. More
than nine out of ten women who died from …pre-eclampsia
between 2006 and 2008 had sub-standard care. Of these 64% had
“major” substandard care where “different treatment may have
altered the outcome.
Substandard care of pre-eclampsia has been a persistent feature of
all similar inquiries over the past two decades.
These findings highlight basic failures in management and
organisation of care in the community and in hospital.
Every death from pre-eclampsia is tragic but is the tip of an
iceberg of many more tragedies, deaths of babies, “near misses”
and serious ill health caused by pre-eclampsia.
The underlying issues of management, are complex – including
staff shortages, a focus on “normal” pregnancy to the detriment of
safety, and fragmented care because of new shift systems – while
the cause of pre – eclampsia is still poorly understood.
However there is no excuse for the basic errors of failure of
detection and lack of adequate control of blood pressure.
We believe that all healthcare professionals who may come into
contact with pregnant women (whether in a GP surgery, antenatal
clinic, emergency department or labour ward must be able to
recognise and act on the clinical signs (hypertension, protein in the
urine) and symptoms (upper abdominal pain, headache, visual
disturbance in the mother or reduced foetal movements/small
baby) of pre – eclampsia.
Critically we need to identify what workable systems will improve
the situation. We want a careful analysis of maternity care,
including the major quality measures that are used to assess
practice.
22 www. thetimes.co.uk/letters
30
Without this unnecessary maternal and baby deaths and adverse
health outcomes will continue.”
4.7 Safety ratings by Dr Foster
Dr Foster is an independent organisation dedicated to helping patients
make informed decisions about their health. Dr Foster Intelligence was
launched in 2006 as a joint venture between the NHS Information Centre
and Dr Foster Holdings LLP.
For many years Dr Foster Intelligence has produced annual reports called
The Hospital Guide. In 2009 that report (entitled “How Safe is your
Hospital”) was all about safety.
The figures in that report do not tell us anything about the absolute
number of medical adverse events but they do give a complimentary
perspective of the safety climate in the hospitals where the events occur.
Based on a recommendation from the Healthcare Commission (2009),
relative risk-based indicators were transformed and statisticians
calculated a “z score” for all English NHS hospital trusts and gave them a
safety rating out of 100. The higher the number, the safer the hospital.
The results are surprisingly wide ranging and overall, bad.
One trust (in London) scored 100 and one (just outside London) scored
zero.
10% of trusts score 90 or ,more.
77% of trusts scored less than 75.
47% of trusts scored less than 50.
These scores provide yet further evidence that hospital safety is a
profound problem, not yet properly addressed. 50.
These scores provide yet further evidence that hospital safety is a
profound problem, not yet properly addressed.
4.8 The number and cost of claims by specialty
As will be discussed in Chapter 7 of this paper there is a vast cost to our
society associated with the life long care of the CP children referred to in
31
Para 4.6. Only a small percentage of CP children crystallise that cost into
an accelerated sum (usually in the form of annual payments) by making a
legal claim. The cost to society for their necessary care remains in all
cases, claim or no claim.
The National Health Litigation Authority (NHSLA) produces an annual
report explaining and detailing the amount it pays out in claims. This is
dealt with further at Para. 7.3.7. Here, having just looked at medical
specialties, we wish only to point out the weighting of claims (in numbers
and value) between specialties.
In 1995 the NHSLA created a new “scheme” for dealing with claims: the
Clinical Negligence Scheme for Trusts (“CNST”). The following tables
(from the NHSLA’s 2010 annual report) describe the total compensation
paid over the subsequent 15 years.
Table 2
Total value of reported CNST claims by specialty as at 31/03/10
(since the scheme began in April 1995, excluding "below excess" claims
handled by trusts)
32
Table 3
Total number of reported CNST claims by specialty as at 31/03/10
(since the scheme began in April 1995, excluding "below excess" claims
handled by trusts)
It is perhaps striking that 3 specialties: obstetrics & gynaecology
(“O&G”), surgery and medicine (in the US this is more easily understood
as “internal medicine”) account for the overwhelming number and cost of
claims. The number of claims over 15 years for those three disciplines
was 44,159 compared with 12,906 claims for all remaining disciplines.
The cost of the claims in compensation and legal (and medical expert)
costs for the same period was 7.6Bn for those three disciplines compared
with 1.3Bn for all remaining disciplines.
Of those three disciplines, one: O&G accounted for 4.4Bn - nearly half
the entire cost. This is simply because of the devastating effect and life
33
cost of care of CP sufferers. Most worst case CP (the majority of them are
worst case) claims result today in damages awards of £5-10M each.
4.9 International comparative data for medical adverse events
Having looked at the overall (and some of the specialty) incidence of
medical adverse events in the UK we return to the comparative data for
medical adverse events in other countries. It had been though that there
was a wide divergence between incidence of such events between for
example the US, the UK and Australia.
However it now seems that the incidence may be much more evenly
spread than had been thought. A Dutch study23 (performed in various
different countries) concluded that adverse events during hospital
admission affect nearly one out of 10 patients and that a substantial part
of these events are preventable.
It further concluded that since a large proportion of the in-hospital events
are operation or drug-related, interventions aimed at preventing these
events have the potential to make a substantial difference.
There is some data on patient safety measures in certain European
countries: Ireland, Belgium, France, Spain, Poland and the Czech
Republic but with very little data for the UK and The Netherlands due to
“very poor response rate” by hospitals to researchers.
The paper “Application of quality improvement strategies in 389
European hospitals: results of the MARQuIS project”24 describes how EU
hospitals have applied seven quality improvement strategies previously
defined by the MARQuIS study: including patient safety systems.
Hospitals were asked how patient safety was organised and managed,
whether the results were reported, and if so, how they were reported.
Responsibility for patient safety was assigned to a committee or person in
approximately 75% of the hospitals. At 39.1% of the hospitals a risk
management programme or system was in place; 50% of the hospitals
systematically reported and analysed adverse events, and 55.6% also
23 ‘The incidence and nature of in-hospital adverse events: a systematic review’. EN de Vries, MA Ramrattan, SM Smorenburg,
DJ Gouma, MA Boermeester. Quality and Safety in Health Care, 2008; 17: 216-223
24 Quality and Safety in Health Carequalitysafety.bmj.com
Qual Saf Health Care 2009;18:i28-i37
34
reported complications to the medical staff. These are average numbers
for Europe; variation between countries was substantial. Irish hospitals
scored consistently high (>90%), and Belgium and Spanish hospitals
relatively low on the availability of safety systems.
4.10 Comment
It is possible reasonably to conclude that there are a very large number of
medical adverse events in hospitals in the UK and in developed countries
abroad.
There is no reason to believe that the incidence of medical adverse events
is any lower in private hospitals. The Dutch study, just mentioned gives
no comfort on that score.
Also of note; these figures bear no relation to adverse events in primary
care. A study of data from the US25 concluded that the burden of severe
outcomes and death from malpractice claims made against primary care
physicians was greater in primary care outpatient settings than in
hospitals.
There is an emerging consensus that interventions (some – like the safe
surgery checklist - simple and obvious) are available to reduce
substantially the number of medical adverse events.
5 THE CAUSES OF MEDICAL ADVERSE EVENTS
5.1 Systemic causes
In the UK, in injury litigation arising out of a medical adverse event in an
NHS hospital, it is no coincidence that the person against whom the claim
is generally directed (the defendant) is not the doctor who treated the
patient but the NHS Trust which employed that doctor.
The reason for that practice is that even at the outset of legal proceedings,
much remains to be discovered. This is despite the fact that a full
investigation by doctors invited by the claimant has taken place The
suspicion is that, if not already apparent, it may soon be revealed by the
defence that the accident was not entirely due to the neglect or “fault” of
the doctor in question but by a much broader organisational or systemic
problem that lay at the root of the issue.
25 Qual Saf Health Care 2004;13:121-126 doi:10.1136/qshc.2003.008029
35
5.2 Bupivacaine and vincristine
One classic and well reported example of the systemic cause is the
notorious cases of people who died after receiving bupivacaine (an
anaesthetic). In one case, the woman in labour should have received
normal saline intravenously, but a nurse accidentally selected a virtually
identical bag of bupivacaine located in the same unlocked drawer as the
saline. The expectant mother developed seizures and a cardiac arrest that
could not be treated successfully.
Another classic is the intrathecal (inside the sheath around the spinal
cord) administration of the drug vincristine:
“a rare event but catastrophic for the patient, family and clinical
team involved. Analysis of this source of harm shows it to be a
classic systems error which has proved intractable for nearly 40
years. Failure to learn from history, communicate safety solutions
nationally and internationally, create safety agencies which
effectively and reliably prevent adverse events, conduct
investigations and enquiries which fully reveals how to mitigate
system error, develop robust physical design solutions to prevent
harm to patients, make effective solutions universal and preparing
for the unexpected are all major challenges.”26
The Crown Prosecution Service dropped a 1999 case of medical
manslaughter after deciding that the death was the result of a catalogue of
mishaps and failings in the hospital system rather than gross negligence
by the doctors.27
5.3 The Select Health Committee’s (“HSC”) view
The HSC is appointed by the House of Commons to examine the
expenditure, administration, and policy of the Department of Health and
its associated bodies. In its 2009 paper “Patient Safety” it concluded:
“Errors in health care are usually provoked by weak or inadequate
systems within and across health care organisations. These events
are not random, one-off unconnected events. They often have
common root causes relating to weakness, breakdown or
dysfunction within an organisation's operational methods,
processes or infrastructure.” 28
26 The quest to eliminate intrathecal vincristine errors: a 40-year journey; Douglas J Noble, Liam J Donaldson; Postgrad Med J
2011;87:71-74 doi:10.1136/qshc.2008.030874rep
27 BMJ. 1999 January 16; 318(7177): 148.
28 Published on the 18th June 2009
36
5.4 Detailed investigation rare
Sadly the detailed investigation of medical adverse events is not routine.
“In most high-risk industries, learning from accidents and nearmisses is a long-established practice and a cornerstone of safety
analysis and improvement. Aviation accidents, for instance, are
exhaustively investigated, and the lessons learned are disseminated
widely, with important changes made mandatory by regulatory
authorities. In contrast, learning within the health care sector, with
some notable exceptions, has generally been fragmentary and
uncertain.” 29
Professor Charles Vincent, one of the UK’s champions of patient safety,
continues in the same paper:
“Studies of accidents in industry, transportation, and the military
have broadened the understanding of accident causation, reducing
the focus on the individual persons who may have made an error
and aiming it instead on pre-existing organizational factors.”
The paper goes on to describe how medical adverse events might
effectively be investigated for the benefit of all actors.
The absence of just such (or any acceptable and efficient method of )
investigation is at the heart of the problem in the view of some. Peter
Walsh the Chief Executive of the well respected charity Action against
Medical Accidents (AvMA) speaking on the subject of fatalities in health
care said
“a tiny percentage of medical adverse event deaths result in an
inquiry let alone an inquest; especially the elderly - they slip away
unnoticed”30
Dr Foster reports
“39 per cent of hospitals do not investigate all unexpected deaths
or cases of serious harm that occur on their wards. Latest analysis
shows there is still wide variation in safety standards
among our hospitals, with patients often at risk from clinical errors
and poor management. … 9 per cent of hospitals do not discuss
clinical outcomes, and 10 per cent do not have patient safety as a
constant item on their board agenda……The recent roll-out of
hospital guidelines, operating checklists and incident reporting
systems have still not created the safety culture that NHS patients
should expect…….Between 5 and 17 per cent of hospitals say they
29 Understanding and Responding to Adverse Events Charles Vincent, Ph.D.; New England Journal of Medicine 348;11
30 Death Matters Symposium 18 June 2010
37
do not discuss safety with commissioners……………….The NPSA
has tailored a version for use in the NHS. But eight hospitals say
they do not bother to use it..”31
The absence of proper investigations into the causes of medical adverse
events makes identification of the causes (and hence the remedies against
further errors) difficult. As will be seen in the next chapter some research
has been done by specialty.
5.4 International Classification of Diseases Classifications Y40-Y84
It might help if we had a functional annual official reminder of the
number of deaths caused by medical adverse events. The Office of
National Statistics produces annual Mortality Statistics. Causes of death
for those statistics are classified according to the International
Classification of Diseases (ICD) published by WHO.
The current classification ICD 10 is the latest in a series which has its
origins in the 1850s.The ICD is the international standard diagnostic
classification for all general epidemiological, many health management
purposes and clinical use.
These include the analysis of the general health situation of population
groups and monitoring of the incidence and prevalence of diseases and
other health problems in relation to other variables such as the
characteristics and circumstances of the individuals affected,
reimbursement, resource allocation, quality and guidelines.32
The WHO publishes “Injury Prevention and Control - A Handbook for
Undergraduate Medical Curriculum” and suggests it is to be
incorporated in the teaching–learning programmes of medical
undergraduates.
It explains that ICD 10 Classifications Y40-Y84 are generically described
as “Complications of medical and surgical care”. Those classifications
consist of a few hundred sub classifications of many of the types of
medical adverse events that are very well known to clinical negligence
lawyers and risk managers.
31 Dr Foster’s Hospital Guide 2009
32 WHO website (http://www.who.int/classifications/icd/en/)accessed 6/7/11.
38
For example Y63 is “Failure in dosage during surgical and medical care”
and of the various sub categories Y63.8 is “Failure in dosage during other
surgical and medical care”. Classification S00-T98 is “Injury, poisoning
and certain other consequences of external causes”:
We know from Para 7.3.1 that it has been estimated that adverse drug
reactions (both preventable and non-preventable) are likely to account for
over 10,000 deaths in England a year.
Yet according to the Mortality Statistics for 200933 nobody died from
Y63 (failure in dosage).
More generally classification Y60-Y69 is “Misadventures to patients
during surgical and medical care” According to Table 7 of the same
Mortality Statistics a total of 20 females and 6 males died from such
misadventure during medical care.
Such disparity between the notified figures for medical adverse events
and the DoH adopted figure of 72,000 appears bizarre.
It is known that the WHO is very concerned about medical adverse
events. It is not known precisely why Classifications Y40-Y84 were
included in the ICD but it is reasonable to suppose that WHO wanted to
give nations the opportunity to measure medical adverse events
both in absolute terms and by cause.
Many of the ICD classifications relate to disease generally. These no
doubt are generally certified by doctors. The same we take it applies to
the Classifications Y40-Y84.
The opportunity to measure at least the lives lost by medical adverse
events is evidently being squandered by doctors’ failure to heed the
WHO’s requirements regarding the classification of causes of death.
5.6 Failure to Learn from mistakes
As Professor Vincent makes clear (para 5.4 above) the ability of the
medical profession to learn from its mistakes has not been good.
The then CMO Sir Liam Donaldson wrote “An Organisation with a
Memory” (OWAM) with this problem to the forefront of his mind.
“The present NHS position on adverse incidents
Some failures occur which are avoidable.
33 Office for National Statistics website accessed 6/7/11
39
Untoward events which could be prevented recur,
sometimes with devastating consequences.
Incidents which result in lapses in standards of care in
one or more health organisations do not reliably lead to
corrections throughout the NHS.
Circumstances that predispose to failure, and which if
addressed could allow risks to be minimised, are not well
recognised.
The price of failure
1.15 The importance of addressing this deficit – the failure to learn
reliably from adverse events – is illustrated by seven simple
facts:”34
[he went on to point out some of the information set out in Paragraphs 4
and 7 of this paper as to the incidence and cost of medical adverse events]
Eight years later the National Audit Office (NAO) in its evidence to the
HSC for the 2009 paper “Patient Safety” was more scathing. It recalled
that the DoH expected the NPSA to have effected 60 per cent of trusts to
be in a position to provide information for learning, to the national
reporting system by the end of that year, and the remaining 40 per cent by
the end of 2002.
“The NPSA's National Reporting and Learning System was not
operational in terms of collecting information from all trusts until
early 2005 and it [took] until early 2008 for the system to reach
what some might consider an acceptable incident reporting rate.
This is a substantial over-run when measured against the original
timetable.”
The NAO continued with some force:
“This observation is not an arcane point about project
management. The principal purpose of the NPSA was to save lives
and prevent injuries to patients through learning from experience.
Any delay in implementation thus denies patients the benefit of that
learning and, by extension, means that patients may have died or
suffered harm as a result of incidents that could have been averted
with the knowledge coming from an effective national reporting
and learning system (NRLS).”
“Given the sums of money that have been spent on the NPSA over
the past seven years, there appears to be surprisingly little
evidence of any significant learning coming from the NRLS.
34 An Organisation with a Memory DoH 2000, Introduction para 5
40
Indeed,….. our understanding is that the NPSA appears to have yet
to determine exactly how it will analyse the incident data collected
since 2004.”
5.7 Comment
If we knew and learnt from reporting all medical adverse events, thereby
what had been their root causes, it would be much easier to avoid them in
future. Although this principle has been well established in life generally
and more recently in medicine particular it appears we may be some way
from achieving that art.
6 THE TOLERABILITY OF RISK
6.1 Introduction
When we go into hospital because we are ill or need an operation to
improve function (or even appearance) most are prepared to accept some
risk as a result of things going wrong. The risk we accept is that of some
complication of the illness or surgery rather than an adverse event as
such.
We weigh the risk instinctively perhaps (rather than scientifically) and
decide whether to proceed with, defer or decline an operation.
The law requires that we are informed about any appreciable risk and will
compensate a person who is kept in the dark about such a risk that later
materialises.
Clinicians are appraised of the precise statistical risk in respect of certain
procedures, but then sometimes infer that the number provided covers a
wide range of (say) surgeons and that in the hands of very skilled
surgeons the risk is lower.
There is little discussion with patients of the overall risk that of course
very much includes medical adverse events. As far as we have been able
to ascertain there is little state assessment of the overall risk of medical
treatment. There is insufficient investment in safety. There should more
appreciation of the potential benefit of steps the state might take to
ameliorate those risks in a largely state run industry.
Perhaps for historical reasons however, industry generally in the UK
(largely private in nature) is subjected to considerable state risk appraisal.
6.2 Risk in Industry
Here we defer to an expert in the field. Andrew W Evans, is a Professor
of Transport Risk Management at Imperial College London. His work
covers rail and road accidents and includes important consideration of
41
linked economic issues in relation to the return on investment in safety. In
2004 he published a paper discussing the conventional approach to the
appraisal of risk and subsequent investment in safety in the context of
roads and railways. He came to a conclusion about the (researched) view
society took about the relative risk and respective investment in safety on
the roads and railways.
He did not consider the acceptable risk or investment in safety in
medicine. That is not his field. However his explanation of the principles
involved are instructive. The following are pertinent extracts from his
paper “Railway Risks, Safety Values And Safety Costs, Version 2”35:
August 2004:
“The standard framework for appraising risks and safety measures
on the railways is the ‘Tolerability of Risk’ (ToR) framework, first
propounded by the Health and Safety Executive (HSE) in the
context of nuclear power stations in 1988, and revised in 1992
(HSE 1988, 1992).
The ToR framework was re-presented by the HSE (2001) in their
policy document Reducing Risks, Protecting People, and is now
widely accepted as applicable to other risks besides nuclear”.
“The ToR framework combines a near-prohibition on relatively
high levels of individual risk with a considered trade-off between
risks and safety benefits at lower levels of risk. The trade-off is
generally described as the principle that risks should be ‘as low as
reasonably practicable’ (ALARP).
The simplest interpretation of the benefit/cost comparison is that if
the benefits of a safety measure are greater than or equal to its
costs, the safety measure should be implemented. On the other
hand, if the benefits of a safety measure are less than its costs, the
safety measure should not necessarily be implemented. This is
broadly the interpretation placed on it both by the railway
industry……and by the HSE. The HSE also refer to the Edwards v
National Coal Board court case (All England Law Report, 1949),
which states that a safety duty holder must implement safety
measures up to the point at which the costs are not merely equal to
the value of the risks, but ‘grossly disproportionate’ to them.
35 Evans, A W (2005) Railway risks, safety values and safety costs. Transport, part of the Proceedings of the Institution of Civil
Engineers, Vol 158, 3-9
42
The quantitative application of the ToR framework thus in
principle requires two sets of parameters. The first set is the
boundary or boundaries between tolerable and intolerable levels of
individual risks. The second set are the values of preventing
casualties…
The boundary between tolerable and intolerable individual risks is
widely accepted as being an ethical judgement. In their original
presentation the HSE proposed that the upper limit to the tolerable
risk of death for employees should be 1 in 1,000 per year and that
for third parties should be 1 in 10,000 per year. These values have
stood the test of time and are the same in the HSE’s most recent
policy document Reducing Risks, Protecting People (HSE, 2001).
The second set of parameters are the values of preventing
casualties. The Department for Transport (DfT) and its
predecessors have estimated such values for some 50 years for use
in the appraisal of road investment and road safety projects. Their
methods have evolved over time.
The widely accepted principle for valuing the effects of public
policies or projects is that these should be valued according to the
preferences of those who are affected. In safety, these preferences
are now measured by estimates of people’s ‘willingness to pay’ for
risk reductions in specified contexts.
The DfT’s valuation of preventing a fatality (VPF) is based on the
total amount that a large group of people would be willing to pay
for small reductions in risk to each person that could be expected
on average to save one fatality among them. The DfT’s most
recent published VPF for the roads is £1.59 million for 2009. This
figure also includes the public costs of fatalities such as medical
costs.”
“When British Rail adopted the ToR framework in the early 1990s,
they needed a VPF for railway fatalities. After substantial internal
debate, but no public surveys, they adopted…………. a roundfigure VPF of £2 million for fatalities in train accidents……… As
the roads VPF has been increased in the following years……. the
VPF for fatalities in train accidents was £3.46 million (Railway
Safety, 2002).
43
Therefore the broad conclusion [from two major empirical
research studies to estimate the rail VPF relative to the roads
value] is that the public, including regular rail users after a major
accident, appear to place much the same value on the prevention of
rail fatalities as they do on preventing road fatalities. The
Government’s formal position is that the VPF for the prevention of
fatalities in rail accidents should be the same as that in road
accidents (McIntosh, 2003).
We began this section with a discussion of the ToR framework,
which in principle requires the implementation of all safety
measures for which the value per prevented fatality exceeds the
cost. It is clear from Table 3 that the ToR framework is not applied
in practice to the road system, because there are many potential
road safety measures for which the value exceeds the cost, but
which are not implemented. The reason for non-implementation is
the constraint on resources, but in other fields resource constraints
are not accepted as a valid reason for non-implementation of
reasonably practicable safety measures.
On the other hand, the railways go beyond the requirements of the
ToR framework in the field of train protection. Although BR-ATP
was not implemented across the network, the cost per fatality
prevented by TPWS as implemented exceeds its value. Even with
the more limited version of TPWS originally envisaged, the cost
per fatality prevented appears to be slightly greater than the higher
of the two VPFs used by the Railway Group, and that VPF is not
supported by the ‘willingness to pay’ evidence discussed in section
3.2.2. Furthermore the individual risks on the railways are
relatively low, so there is no case for special safety measures to
prevent the risks being intolerably high. Therefore TPWS as
implemented is not justified within the ToR framework alone.
Indeed, it was for that reason that specific regulations were made
effectively to override the ToR framework (HSE, 1999).
Nevertheless, it is notable that TPWS has been almost universally
welcomed, because it has substantially reduced a persistent and
important source of railway risk.
It is clear from the preceding discussion that society could prevent
more fatalities at the same cost by devoting relatively more
resources to road safety and less to rail safety. It remains a puzzle
44
that society chooses not to do so, and is apparently content with the
present allocation of resources.”
6.3 The tolerable risk of death to a patient by a medical adverse event
In the context of NHS hospitals, it must be asked - should the same level
of individual risk from accident, apply in a hospital as applies to many
other walks of life: those governed by the HSE?
In other words are we more willing to die from an accident in hospital
than on the roads or railways? We probably would not take the risk of a
journey by any means if we knew there was a high risk of death. There
are clearly some medical conditions that are so catastrophic and/or the
risk of death from the condition itself so high, that an “heroic” or risky
procedure might be acceptable to the patient. But this likely does not
apply to the vast majority of NHS hospital “episodes”.
We also have to bear in mind an overriding principle of medical ethics
derived from Hippocrates and embedded in medical culture for centuries:
“first do no harm”. This principle certainly applies in the decision making
process when individual clinicians balance the risks and benefits of a
procedure but there has been little evidence of detailed analysis of the
inherent risks of systemic error.
Assuming for the purpose of this exercise that the same values should
apply to medicine as other walks of life, we examine the relative values.
The upper limit of the value of the risk of death (as defined by HSE) was
described in para. 6.2 above in the context of nuclear power stations in
1988. That was only two years after the disaster at Chernobyl in Ukraine,
fallout from which has been predicted by WHO to cause in total between
30,000 and 60,000 deaths.
Contrasting again the risk of death from transport (another perceived high
risk activity) much lower values are found. Deaths are measured per
billion passenger km. The risk varies by mode of transport. Deaths per
billion passenger km travelled, occur by air to 0.02 people, by rail 0.9, by
water 0.3, and by car to 2.8 people36. If one takes the riskiest of those: the
car journey and consider a drive of the length of Britain the risk of death
would be immeasurably low – 3 in a million.
Clearly the accepted upper limit of the value for the individual risk of
death of employees (of 1 in 1,000) introduced by HSE 23 years ago, is
not appropriate. This is because the employee is exposed to risk 7 or 8
hours a day for 5 days a week, over say 46 weeks a year.
36 http://plus.maths.org (a Cambridge University website)
45
The more appropriate upper limit value would appear to be that for third
parties: 1 death in 10,000 per year.
If this is the standard then how does the NHS perform? To answer that
question one needs to look at the number of NHS patient episodes. The
number of NHS hospital episodes in the period March 2010 to February
2011 is set out in Table 4 below37.
Table 4 NHS Patient Episodes 2010-2011
Inpatient Consultant Episodes
17.3M
A&E attendances
16.2M
Outpatient appointments attended
70M
The Vincent figures which are generally accepted and we have been
using only relate to hospital admissions, not any deaths resulting from
A&E attendances or outpatient appointments. Therefore we take no
account of those for this purpose.
Taking therefore only the annual 17,300,000 inpatient episodes and the
72,000 deaths due to medical adverse events, one comes to a value of
adverse deaths (those not caused by the underlying medical condition) of
1 in 240 hospital admissions. This compares in scale to the 1 death in 300
patients going into hospital we saw attributed by Sir Liam Donaldson to
Professor Lucian Leape in Para 4.2.
Put another way the actual risk of being admitted to an NHS hospital is
40 times as great as that considered acceptable by HSE as the upper limit
value for third parties in high risk premises: 1 death in 10,000 per year.
It follows that 1 in 480 patients being admitted to NHS hospitals in
England die as a result of negligence or avoidable, preventable medical
adverse events.
Most people (if they knew it) would find this level of risk utterly
unacceptable. It is clearly outside all the boundaries for other high risk
activities.
It is worth reflecting that across Whitehall there has been much careful
independent academic thought over several decades about socially
acceptable risk, the economic return on investment in safety measures
37 NHS Information Centre (accessed 17/6/11)
46
and about saving lives in the realm of one government department but
apparently rather less in another.
Of course the two departments are very different in so many ways. But
fundamentally the purpose of both is the same: to promote and (to a
varying degree) regulate the provision of safety and health.
In one arena death has become a rare and shocking event, routinely
reported in the media whenever it occurs. In the other nobody knows how
many people die needlessly save that they are far too many. They often
go uninvestigated (so nobody learns the lessons) and usually unreported.
What is an acceptable risk has not been published (save by procedure),
nor has the cost of avoiding medical adverse events.
We agree with Professor Evans’ observation that it remains a puzzle that
society chooses not to invest more in safety on the roads instead of the
railways.
The elephant in the drawing room is surely, the relative failure to address
the risks to us all of medical adverse events that kill annually ten
thousand times the number of people than railways.
7 THE COST OF MEDICAL ADVERSE EVENTS
7.1 The Distribution of the Cost of medical adverse events
7.1.1 Introduction
This chapter deals only with financial cost except where specifically
mentioned.
We cannot find any research performed in the UK on the subject of either
the total financial cost of medical adverse events or the distribution of
such costs. It is self evident that the costs will be born by many parties
including: society (in the shape of the welfare state and the Exchequer (as
to lost revenue) the NHS Litigation Authority (“NHSLA”) that meets
compensation claims, the vast majority of injured patients (who do not
claim) and their families, the NHS Trusts and so on.
47
7.1.2 There is however some research in the US on the question of the
distribution of costs.38 It will be noted that there are a number of
significant differences in funding healthcare and errors arising in the US.
There is no equivalent to the NHS; there is little welfare state so people
seriously injured by medical adverse events are not supported at the
state’s expense.
7.1.3 Despite these differences the paper “Who Pays for medical errors?”
has some bearing on the position in the UK as the same general principles
apply.
The paper concludes
“Patient safety advocates argue that the high costs of adverse
events create economic incentives for hospitals to invest in safety
improvements. However, this may not be the case if hospitals
externalize the bulk of these costs. On average, the sampled
hospitals….bore only 22 percent of these costs. Legal reforms or
market interventions may be required to address this
externalization of injury costs.”
“The findings of our analysis indicate that the overwhelming
proportion of the costs of hospital medical injures are shifted to
parties other than the hospital. We conclude that the direct costs of
adverse events do not fall on hospitals to a significant enough
extent to create strong economic incentives for safety
improvement.”
7.1.4 The data published in the UK relating to the cost of medical
adverse events has related largely to the cost to the NHS, in terms of, for
example, the additional bed days caused by those events, the cost of
ADEs, hospital acquired infection and the cost of compensation claims
and related legal costs paid out by the NHSLA.
7.1.5 This chapter seeks to address not merely the above NHS costs but
the overall cost to society of medical adverse events.
38 Who Pays for Medical Errors? An Analysis of Adverse Event Costs, the Medical Liability System, and Incentives for Patient
Safety Improvement; Michelle M. Mello 1*, David M. Studdert 2*, Eric J. Thomas 3*, Catherine S. Yoon 4*, and Troyen A.
Brennan; Journal of Empirical Legal Studies Volume 4, Issue 4, Pages 835-860
48
7.2 The cost of medical adverse events to Clinicians
This cost though real is difficult to measure in financial terms. Professor
Vincent describes this element of cost eloquently.
“The aftermath of an adverse event can also have profound
consequences on the staff members involved, particularly if an
individual member is seen, rightly or wrongly, as primarily
responsible for the outcome. After making a mistake, caregivers
may experience shame, guilt, and depression; litigation and
complaints impose an additional burden. In some cases, doctors or
nurses may become very anxious about practicing clinical
medicine, seek out a specialty with less direct patient contact, or
abandon medicine entirely. Wu expresses the typical reaction of
the clinician in such a situation, whom he aptly describes as "the
second victim," thus:
“Virtually every practitioner knows the sickening feeling of
making a bad mistake. You feel singled out and exposed —
seized by the instinct to see if anyone has noticed. You
agonize about what to do, whether to tell anyone, what to
say. Later, the event replays itself over and over in your
mind. You question your competence but fear being
discovered. You know you should confess, but dread the
prospect of potential punishment and of the patient's anger.”
The reaction of the patient and his or her family may be hard to
bear, especially if the outcome is severe and if there has been close
involvement between the patient and the clinician over a long
period. The reaction of colleagues, whether supportive or defensive
and critical, may be equally powerful. Clinicians, like everyone
else, vary in temperament, resilience, and attitude with respect to
their own errors. To a highly self-critical person, errors and
mistakes may be particularly disturbing. The high personal
standards of excellent clinicians may in fact make them
particularly vulnerable to the consequences of mistakes. This
tendency is generally reinforced during medical training; the
culture of medical school and residency implies that mistakes are
unacceptable and, when serious, that they point to a failure of
effort or character.”
49
“Highly qualified doctors or nurses may become very anxious
about practicing clinical medicine, seek out a specialty with less
direct patient contact, or abandon medicine entirely”19 .
We have known this happen. Not having any means of valuing this cost,
we do not attempt to do so but there must be a significant cost to be added
to the figures reached below. The cost involved includes the additional
cost of re-training or training anew, substitute staff.
7.3 The cost of Medical adverse events to the NHS
This paragraph deals only with part of the cost of medical errors that are
internalised to the NHS. Many of these costs have not been separately
estimated.
7.3.1 The cost of Adverse Drug-Related Events (ADEs)
It has been estimated that around 4% of all hospital admissions are due to
preventable ADEs. Adverse drug reactions (both preventable and nonpreventable) are likely to account for over 10,000 deaths in England a
year, taking account of those reactions that also occur during a hospital
stay. The estimated annual cost of preventable medicines-related
admissions in England is said to be £466 million. 39
7.3.2 The cost of adverse Venous Thromboembolisms (“VTE”)
The 2009 HSC report Patient Safety found40 that the cost of treating the
long-term disability caused by VTE was around £640 million a year. As
we saw in Para 4.6.2 (referring to the deaths) much of this is preventable.
The disability arises in the survivors. Clearly some progress has been
made. That paper described the proposed protocol inpatient admission
VTE assessment. That paper contained this contribution on the economic
benefits of prevention:
“The probability of saving lives and reducing long-term
complications for patients are, in themselves, sufficient reasons for
NHS organisations to take these steps [preventing VTE]. But both
providers and commissions could also see financial benefits if
cases of VTE decrease – preventing VTE could improve
productivity for providers, potentially shortening average lengths
19 Understanding and Responding to Adverse Events Charles Vincent, Ph.D.; New England Journal of Medicine 348;11
39 Pirmohamed et al, Adverse drug reactions as cause of admission to hospital, BMJ, 2004.
40 Ibid. Footnote 4.
50
of stay whilst reducing future admissions and costs of ongoing care
for commissioners.”41
Data collection on provider compliance and communication of the data
to DoH, was made mandatory for all NHS providers from June 2010.
However as will be seen in Para. 12.2.5 progress has been patchy.
7.3.3 The cost of Hospital Readmissions to the NHS
The government has strengthened from 1 December 2010 a previous
understanding that avoidable readmissions due to poor quality care were
not reimbursed. The announcement on 8 June 2010 by Secretary of State
for Health Andrew Lansley MP not to pay hospitals for all unnecessary
readmissions within 30 days could affect up to £1.5Bn of NHS funding,
based on 2009 figures. The total national cost of readmissions in 2009 at
standard tariff was £1.5Bn42. ….The new NHS Operating framework
says:
“there is now an intention to ensure that hospitals are responsible
for patients for the 30 days after discharge. If a patient is
readmitted within that time, the hospital will not receive any
further payment for the additional treatment.”43
7.3.4 The cost of hospital acquired infections (HAIs)
Clearly not all hospital acquired infections are preventable. However the
Public Accounts Committee of the House of Commons has visited this
subject with an eye to the public savings to be made. It appears to accept
the view held by many that certainly most hospital acquired infections are
preventable.
In its latest report it said
“Whilst some experts believe that not all hospital acquired
infections are preventable, some trusts have zero tolerance to
avoidable infections…..since the implementation of the MRSA
target in 2004, there have been savings in treating MRSA
bloodstream infections against the baseline of around £45 million,
and savings as a result of the reduction in C. difficile since 2007 of
around £96 million. This illustrates the cost benefits of prevention
and, if similar success could be achieved in reducing the other
41 NHS Confederation Briefing, May 2009
42 http://www.publicfinance.co.uk/news/2010/12/nhs-productivity-barely-rose-last-year/
43 7, 14 and 28 day readmissions rates in conjunction with current tariffs to explore
the impact of possible changes to funding levels in the NHS. Dr Marc Farr, product development manager, Dr Foster Intelligence
51
80% of healthcare associated infections, there should be scope for
further significant savings to be made.44
According to The National Audit Office (NAO)
“The best estimate of treating healthcare associated infections
therefore remains at least £1 billion, as quoted in our initial report
in 2000 and our follow up in 2004. The cost of treating a
healthcare associated infection varies, but the Department’s
productivity calculator estimates that each avoidable healthcare
associated infection costs the NHS £4,300.”45
7.3.5 The cost of additional bed days brought about by medical adverse
events
The Vincent Study (see footnote 1 for the reference) did not concern itself
with the general economic costs, nor the human cost to the victims, nor
indeed with the cost of compensation paid by the Health Authorities and
Trusts.
What it did (in terms of cost) was to look at the effect and costs to the
NHS hospitals of immediately treating the patients who were the subject
of these adverse events. The Study found that the annual number of
additional, extended bed days occupied (during the same admission) by
those accidentally injured patients was around six million bed days each
year. The cost of those additional bed days for all adverse events was (in
2001) £1.9Bn each year or about £1Bn per annum if one looks only at the
negligent or avoidable adverse events. Allowing for inflation since 2001
at 24%46 that cost today would be £1.24Bn
7.3.6 The cost of lifelong medical treatment of permanent injuries
The Vincent Study did not look at the long term NHS cost of later
ongoing NHS primary and hospital treatment for those 28% of patients
suffering medical adverse events who are moderately and permanently
injured each year.
This cumulative annual cost of treating all such patients for their whole
life for the ongoing complications of long term injury is likely to be very
44 Reducing Healthcare Associated Infection in Hospitals in England – House of Commons Public Accounts Committee 10
November 2009
45 NAO: Reducing Healthcare Associated Infections in Hospitals in England 12/6/9
46 Thisismoney.co.uk
52
significant indeed. We will propose a modest annual ongoing figure of
10% of the initial costs of the short term treatment multiplied by twenty
to represent patients who have accumulated for each of the past 20 years.
Twenty years is taken as a mid point of life expectancy for those who are
injured when very young and those who are much older when injured and
may not live long thereafter. This amounts to a further £2.48Bn per
annum at today’s values.
7.3.7 The cost of litigation claims
The rule of thumb for the insurance cost for professional indemnity
insurance premiums in high risk professions where claims may be
unlimited, is that they range between 2-5% of turnover.
The NHS does not insure against claims. It saves that cost (£2.2-5.5Bn
per annum) and simply carries the risk. |Unsurprisingly claims are made.
In 2009/10 6652 new claims were made47. The number of claims made
used here are from two separate sources. The figures up to 2003/4 are
from Hansard. At the time of commenting on the numbers of claims in
2006 it was accurately said:
“These figures confirmed the ‘continuation of the downward trend’
in claims numbers that has been evident in recent years.19 They
now are close to the lowest estimate for the year 1990–1991,
coming down from a peak in the period 1997–2002”48.
However the figures have risen somewhat since but are well down on the
peak referred to. Certainly over the last 12 years there has been no overall
increase. The later figures are from the NHSLA Report 2010. There are
two possible explanations for the slight variation: recessions
(commencing in 1997, 2001, and 2007) or a variation in the volume of
medical adverse events.
Table 5: Total Number of Clinical Negligence Claims Reported
(Sources: Hansard & The NHSLA Report 2010)
47 NHSLA Annual Report 2010
48 Tort personal injury claims statistics: Is there a compensation culture in the United Kingdom?(2006) 14 Torts Law Journal
53
Total Number of Clinical Negligence Cla
Reported
3,000
6,088
5,470
5,426
5,697
5,609
4,844
4,000
4,136
5,000
6,257
6,915
7,036
6,000
6,916
6,932
7,000
7,215
8,000
2,000
1,000
0
1996- 1997- 1998- 1999– 2000– 2001– 2002– 2003– 2004- 2005- 2006- 2007- 2008- 2
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2
Against 900,000 medical adverse events (per the Vincent Study and
assumed to be a constant figure – in the absence of better evidence) this
produces since 1996 a rate of claims per adverse event varying (in a
narrow range), between of 0.46% to 0.8%. For 2009-2010 the rate of
claims 0.72%.
“The NAO estimates that one in 10 patients suffers an adverse
event in hospital, ranging from a fall to a fatal error involving
drugs or surgery. Yet only a very small percentage of these adverse
incidents leads to claims for compensation. In the most recent
figures, only 7,205 claims for clinical negligence were registered
between April 2004 and March 2005. This suggests that less than
1% (0.74%) of the patients injured in the NHS each year actually
makes a claim.”49
These are the stand out percentages in the whole claims industry. A
claims rate of less than 1% for medicine compares with one of over 60%
for road traffic accidents.
49 Parliamentary Select Committee on Constitutional Affairs Nov. 2005
54
What is extraordinary about even those figures is that ironically they are
too high as a percentage of claims per actual medical adverse event. The
reason for this is quite simple. Patients do not know (and are certainly
still not told by their doctors) whether a medical adverse event has
occurred still less whether it was avoidable or legally negligent.
According to the NHSLA nearly 50% of claimants drop their claims.
Usually this is because the claim cannot be proved. That is close to
meaning that there was no avoidable medical adverse event.
It follows that for avoidable medical adverse events (as distinct from
events perceived as such), the rate of claims is nearer 0.25% to 0.4%.
We understand that in 2010/11 The NHSLA paid out £1.05Bn in claims,
including all legal and associated (including significant medical expert)
costs. Whilst a large sum it is much less than they might have expected in
premiums had they decided to insure.
We looked at Obstetrics in paragraph 4.6.8 above noting the very high
numbers and value of claims in this specialty. One category of claims
within obstetrics: those for children with cerebral palsy make up
approaching half of all payments by the NHSLA.
“45% of all these NHSLA payments relate to children with
cerebral palsy (although these are only 6% of cases). The cost of
payments to children who may (emphasis ours) have been
damaged at birth is, therefore, very high and Trusts with obstetric
departments would be making large contributions to the
Scheme”50.
With great respect to Professor Dame Joan Higgins, the author of those
remarks any meaning intended by the word “may” should be taken with a
pinch of salt. It should be born in mind that the NHSLA tenaciously fight
every clinical negligence claim. For obvious reasons cerebral palsy
claims are fought more tenaciously than most. If a payment is made by
the NHSLA the claim will have been tested exhaustively as to liability
(breach of duty), causation (scientific link between the breach of duty and
the cerebral palsy) and the amount of compensation due, to the
satisfaction of a battery of legal and medical experts on both sides or a
judge having heard all of them.
7.3.8 Total of cost to the NHS
Any attempt to total these figures for the cost of medical adverse events
to the NHS is faced with a difficulty. The Vincent figures “extra bed
50 Professor Dame Joan Higgins Chair of the NHS Litigation Authority PP presentation 2006-7
55
days” could be seen to exclude readmissions as they expressly dealt with
costs related to the same admission. However they may be seen as
including ADEs and HAIs. The safest thing may be to exclude altogether
for this purpose the older Vincent figures.
Totalling (on that basis) the known estimated annual cost to the NHS
alone:
ADEs
£
466M
Venous Thromboembolisms £640M
Readmissions
1,500M
HAIs
1,000M
Long term treatment
Claims (including costs)
2,480M
1.005Bn
______
£7.09 Bn per annum
7.4 The Cost of medical adverse events to Society
7.4.1"The Value of Prevention"
The concept of value of prevention is one that has been consistently
applied by The Department for Transport (“DfT”) and The Health and
Safety Executive (“HSE”) for approaching twenty years. The NHS
adopted it in 2002 in “Too high a price. Injuries and accidents in London”
a Report prepared by The London Health Observatory (LHO) part of
NHS London.51
The purpose of that Report was to inform health practitioners and policymakers to assist with commissioning and policy decisions regarding the
high number and economic value of all injuries and accidents in London.
This paper, narrower in scope but wider geographically, has the same
broad aims.
The Report purported to include death and injury by “medical
misadventure” reporting the fatal component as 40 (rather than 9,300) per
annum for London. We refer to a similarly flawed 2011 successor
51 http://www.lho.org.uk/Download/Public/7956/1/ia_main_3.pdf
56
Factsheet three pages below, and again to this glaring error , and the
arithmetic, in Para. 12.3.
Before we leave that LHO paper however it is worth noting the value put
on the 2,000 deaths and numbers of injuries, by NHS London (working
with researchers).
“Using the cost data and activity data, and applying the basic
methodology set out in the report, we have estimated the total costs
and injuries to be just under £20 billion.”
That NHS conclusion as to the cost of 2,000 deaths and other injuries
prepares us for a rather larger figure to come, in respect of the rather
larger actual figure for medical adverse events to inpatients within NHS
hospitals across England. It prepares us to consider the value of their
prevention.
The Value of Prevention concept represents an attempt by various
branches of government to look at the entire indicative cost to society of
various types of accidents, in order to calculate the cost of remedying the
lack of safety in those areas.
The HSE’s Economic Analysis Unit (“EAU”) publish appraisal values.
The EAU appraisal values can, according to HSE, be used to
“estimate the benefits of proposed measures which aim to improve
occupational health and safety, and to compare such benefits with
the cost of government intervention.” “The prevention of
workplace accidents and work-related ill health leads to a
reduction in costs to society, and the EAU appraisal values are
used to inform estimates of the size of such reductions in cost.”
The latest figures are found in “2006 (Q3) Short version – [published on]
28/07/08”52 and set out in Table 5 below.
Table 5: EAU Appraisal values (2006)
Fatality
Human cost
Lost output
Resource costs
Total
£991,200
£520,700
£900
£1,500,000
52 Para 189, p 54. Davies et al, (1999), “The costs to Britain of workplace accidents and work-related ill health in 1995/96”, HSE
books.
57
Major injury
£18,400
£16,200
£5,800
£40,500
Other
reportable
injury
£ 2,700
£2,600
£500
£5,800
Minor injury
£200
£100
£50
£350
Average case
of ill health
£6,700
£2,700
£800
£10,100
The EAU figures for fatalities are based on DfT figures. These in turn are
now produced by the Transport Analysis Guidance (“TAG”) Unit of DfT.
The TAG Unit explains that it
“provides guidance on appraising transport interventions against
the Government's accident sub-objective. Transport interventions
may alter the risk of individuals being killed or injured as a result
of accidents through a variety of means. Accident impacts occur
across all modes of transport and affect non-users as well as users.
This Unit provides a framework for appraising all transport
interventions against the accident sub-objective…. The latest
Department for Transport (DfT) values for prevention of casualties
and accidents are based on 2009 road accident data, and are given
for 2009 at June 2009 market prices and values.”
They are set out in Table 6 below.
Table 6: Average value of prevention of road accidents by severity
and element of cost
Cost Element
2009
Casualty related costs
Medical
Accident Lost
Human
and
severity output
costs
ambulance
596,674 5,615
1,175,101
Fatal
161,713
Serious 23,767 14,244
2,959 1,253
14,090
Slight
All
13,225 3,055
48,546
injury
Accident related costs
Damage
Police Insurance
to
cost and admin
property
1,848 291
10,674
245
181
4,907
57
110
2,903
105
122
3,270
£ June
2009
TOTAL
1,790,203
205,056
21,372
68,323
58
Damage
only
-
-
3
52
1,828
1,883
In Paragraphs 3.3 to 5.3 of the 2002 predecessor paper a detailed
explanation was given as to how the figures for value of prevention given
by the DfT for road accidents could be applied to medical adverse events:
in particular by the adoption of the common thread of immediate post
accident hospital treatment costs. In the EAU table above these are
referred to as “resource costs” They were called by Vincent “additional
bed days” as the injured inpatients were already in hospital. They amount
to roughly the same thing: the cost of treating a person after an accident:
one at work, the other in hospital. As the methodology was adopted by
the NHS for “medical misadventure” in 2002, as we have just seen,
further explanation of its application here may be unnecessary.
The additional bed days are referred to (for the hospital accidents or
medical adverse events) in paragraph 7.3.5 above as amounting in 2001
to approximately £1.9 Bn per annum.
Applying that common thread figure of £1.9Bn (the additional bed days)
to the overall value of prevention DfT figures, the 2002 predecessor paper
arrived at a total annual figure for the value of prevention to society (as
distinct from the NHS) of all medical adverse events of £40Bn per
annum.
If one looks only at the value of preventing the “preventable” medical
adverse events, then that figure for 2001 was £20Bn and 24.8Bn today
allowing for inflation.
It struck us as rather odd that the DfT which has no direct relationship
with most drivers should value the benefits to society of prevention of
accidents whereas the DOH, which does have control over its employed
and sub-contracted NHS staff, has not generally carried out a similar
exercise.
There is the flawed NHS London Report just referred to but that misses a
golden opportunity by ignoring the reliable conventional data, both in
2002 and in a 2011 successor “Factsheet” “London key facts –Accidents
59
and injuries”53. Footnote 1 to the Factsheet is explicit. Medical
misadventure and adverse effects are included.
The precise number of such deaths is not given in the Factsheet but the
total annual number of London deaths from all causes (1,790) makes it
clear that the same erroneous source has been used for counting medical
adverse event deaths. We refer again to this glaring error, and the
arithmetic, in Para 12.3.
It is of course valuable to know how much accidents are costing because
it helps focus the mind on prevention.
The DoH does not publish figures for the cost to society as a whole or
even the cost to the NHS of its own accidents. In a paper54 dealing only
with the litigation cost the economist Paul Fenn put it rather well:
“We do not want to minimise the importance of clinical negligence
as a matter of concern to the health service. Indeed, we believe that
each claim is potentially a signal to health sector risk managers of
where they might look for improvements and it is precisely for this
reason that accuracy is essential and that trends are monitored."
To bring this concept of the value of prevention (of fatalities and injuries)
up to date and put it in a European context it is apposite to mention a
recent report published in April 2011“Updating the VPF and VPIs: Phase
1: Final Report Department for Transport55”. This report concluded
“The use of SP methodology is consistent with general European
practice; and the magnitude of the Department’s VPF is well
within the range of values used in European countries.”
7.4.2 The cost of medical adverse events to our benefit system
There is another way of approaching the cost to society of medical
adverse events. We go through the exercise as a cross check to the figure
produced by the DfT’s value of prevention method.
Put simply the 0.72% (let’s say 1%) of medical adverse event victims
who do make a claim that is paid out, have a judge (or someone
53 http://www.lho.org.uk/Download/Public/16960/1/Key%20fact_%20accidents_and_injuries_2.pdf
54 Current cost of medical negligence in NHS hospitals: BMJ 320 : 1567 doi:
10.1136/bmj.320.7249.1567.
55 NERA Economic Consulting
60
estimating what a judge would) decide, first that they were preventable
and then what has been the cost of the event to them. That net figure (for
the 0.72%) amounted in 2010/11 to £764M56.
No-one calculates the cost for the 99%. But someone pays (in the sense of
providing care and substituting wages) and it’s usually the taxpayer in
terms of benefits payable by the welfare state during the period (short or
long) that the former patients is incapacitated and suffers as a result of the
medical adverse event. The remainder of the cost (as discussed at para
7.4.3 below) is borne by the patient personally.
In order to apply the figure of damages awarded to medical adverse event
claimants as a base (a multiplicand), for considering the figure paid by
the welfare state, a number of deductions would have to be made: for the
(generally small) pain and suffering element of the damages and so on.
Broadly though, it is recognised that the majority of any large damages
claim is made up of two elements: the cost of future care and loss of
earnings.
Thus, if one takes the average case of someone seriously injured by a
medical adverse event but who does not claim, those two elements are
precisely the significant costs that will be picked up by the welfare state
in the form of care allowances and disability allowance or income support
or similar benefits.
Given the less than 1% claim rate, without any deductions, the multiplier
(the figure applied to the multiplicand) would be at least 99 to represent
the cost to society of the vast majority of non claimers among medical
adverse event sufferers. We say above “at least” because we have
importantly disregarded the observation at Para 7.6.3 that the true claim
rate is likely well under 0.5%. Thus the multiplier should be more like
200 before deductions.
We propose instead a broad conservative multiplier of 50 to allow for
appropriate deductions such as the benefits system's non payment of pain
and suffering compensation (albeit a small percentage of larger claims).
Applied to the multiplicand of £764M, a multiplier of 50 produces a
figure of a little over £38Bn.
Interestingly this figure is of the same order of scale as the £24.8 Bn
produced by the calculations in the preceding paragraph 7.4.1.
56 NHSLA Annual Report 2011
61
7.4.3 The cost to patients of medical adverse events
Although this paper is particularly about the financial cost to society of
medical adverse events, it is impossible to ignore the largely silent and
unacknowledged toll of death, misery and life long suffering of the
victims. Charles Vincent (speaking largely from his specialist
psychological perspective) put it in an elegantly understated way.
“Medical injuries differ from most other injuries in two important
respects. First, patients are unintentionally harmed by the people
in whom they have placed considerable trust, so their reaction may
be especially powerful and complex. Second, they are cared for by
members of the same profession, and in some cases the same
clinicians, as those who were involved in the injury itself. They may
be very frightened by what has happened and have a range of
conflicting feelings about those involved, even when staff members
are sympathetic and supportive.
A patient's initial reactions to a medical injury are most likely to be
fear, loss of trust, and a feeling of isolation. Traumatic and lifethreatening events produce a variety of symptoms in addition to
any physical injury. Anxiety, intrusive memories, emotional
numBness, and flashbacks are all common sequelae and are
important components of post-traumatic stress disorder. The full
effect of most incidents becomes apparent only in the long term. A
perforated bowel, for example, may require a series of additional
operations and additional time in the hospital. The long-term
consequences may include chronic pain, disability, and depression,
with deleterious effects on family relationships and the ability to
work. Whether a patient who has been harmed actually becomes
depressed and to what degree depends on the severity of the injury;
the support he or she has from family, friends, and health
professionals; and a variety of other factors.
When a patient dies, the trauma to his or her family members may
be very severe, particularly if the death was potentially avoidable.
By analogy, many people who have lost a spouse or child in a road
accident continue, for years afterward, to ruminate about the
accident and about what could have been done to prevent it. They
are often unable to accept, resolve, or find any meaning in the loss.
Likewise, relatives of a patient whose death is sudden or
unexpected may find the loss very difficult to bear. If the death was
avoidable, in the sense that poor treatment played a part in it,
62
relatives may face an unusually traumatic and prolonged
bereavement.”57
Those who continue to see affected patients for decades after their
medical adverse events know that in the more serious cases, the scars
never heal. Over the years a cumulative total of many millions of patients
and their families in the UK alone carry these scars to their graves.
NHS patients who suffer medical adverse events also bear a financial
cost. As discussed the overwhelming majority do not claim and therefore
bear personally that part of the cost not met by the welfare state. For the
purpose of calculating the financial cost to the 99% plus who make no
claim, for the want of any available data we will adopt the same rough
and ready approach from Para. 7.4.2 above.
It follows that the multiplier to be applied to the patient personally, would
be of the order of 49 (99-the 50 already applied). A multiplier of 49
applied to the multiplicand of £764M, 50 produces a figure of over
£37Bn as the cost of medical adverse events lest in the hands of patients
personally. Of course part of this figure is notional and represents the
pain and suffering borne by the patient as it would have been awarded by
a judge or agreed had he sued.
Almost one in eight of the UK population has some form of private
medical insurance. Over 2.5 million people are thought to have private
health care plans provided by their employers.58 Here of course the cost to
the private hospitals of medical adverse events (not specifically included
in this paper) is either paid by the hospitals themselves or merely laid off
and paid (via a premium, plus profit) by the employer as part of the
employee’s remuneration package or by the insured direct.
7.5 Conclusion and total cost of medical adverse events
We have looked at a variety of costs:
Costs to the NHS alone
£7.09Bn per annum
The remaining cost to society per The Exchequer - either
DfT’s Vpf/vpi method (Para 7.4.1) £24.8 Bn per annum or
57 Understanding and Responding to Adverse Events Charles Vincent, Ph.D: N Engl J Med 2003; 348:10511056/toc/nejm/348/11/
.
58 www.HealthInsurance.co.uk
63
The benefit system method (Para 7.4.2) £38 Bn per annum
The cost left in the hands of patients
£37 Bn
per annum.
In total therefore it is reasonable to settle on a figure of between
£31.89Bn per annum and £45.09Bn per annum as the overall cost to The
Exchequer (including the NHS, compensated and uncompensated
patients) of the preventable medical adverse events in English hospitals
alone.
A further £37Bn per annum may be seen as left in the hands of that
overwhelming majority of victims of medical adverse events who do not
claim. This sum represents half of the damages equivalent that is unmet
by the welfare state and include a damages equivalent to represent pain
and suffering.
To the extent that the percentage of those who do suffer actual (as distinct
from perceived) medical adverse events and do claim, are less than 1%,
(possibly as little as 0.25%59 ) these figures are underestimated.
We do not suppose that these figures are precisely accurate. They are not
intended to be so. They are intended to make a conservative attempt to
put a figure on the overall cost to society of medical adverse events.
We will argue that the death and serious injury toll alone has been
insufficient to generate the necessary action to reduce the quite
unacceptable level of medical adverse events.
Inevitably state intervention (funded by the taxpayer) is often driven by
economic factors. It is for precisely this reason that DfT maintain fatality
and injury statistics for particular stretches of road and then (using the
VPF and VPI60) apply them to the cost of road safety improvements
before funding those safety improvements.
We find these figures of the cost to society quite extraordinary and very
shocking; more so perhaps than the 72,000 deaths per annum. We have
more shockingly, come to accept those unacceptable figures for fatalities
and serious injuries.
We hope that the light shed by this paper on the real cost to society of
medical adverse events, is enough to galvanise the desperately necessary
action.
59 see para 7.3.6 above
60 Explained by Prof. Evans at Para 6.3 above
64
8. WORLD ATTENTION TO MEDICAL ADVERSE EVENTS,
8.1 The patient safety movement
It is of some comfort that during the last decade the issue of patient safety
has significantly risen up the international health agenda.
The birth of the Patient Safety Movement was heralded by the publication
of a number of papers addressing the issue including:
1994 Error in Medicine by Professor Lucian Leape61
1995 Harvard Medical Practice Study results
1998 To Err Is Human, Institute of Medicine (US)
2000 An Organization with a Memory (“OWAM”) (DoH: CMO62)
Professor Lucian Leape is a Professor of Health Policy at Harvard
University. He is a health policy analyst whose research has focused on
patient safety and quality of care. He is recognized as a leader of the
international patient safety movement. His research demonstrated the
success of the application of systems theory to the prevention of adverse
drug events. He has published over 100 papers on patient safety and
quality of care.
He is one of an increasing number of people who are emerging as
champions of patient safety. Others that come to mind on an international
scale include Sir Liam Donaldson Chair of WHO Patient Safety,
Professor Charles Vincent Director of the Imperial Centre for Patient
Safety and Service Quality at Imperial College London, Emeritus
Professor James Reason of the University of Manchester. The identity of
others is found in the references to this paper.
The majority are proponents of the view now perhaps held by the
majority of the medical profession that bad systems and inadequate
training are responsible for most failures in health care.
We say most simply because there are preventable medical adverse
events that one senses that good systems and training would not have
been enough to prevent.
The reference by Dr Sophie Berglund (at para 4.6.8 above) comes to
mind:
[it] “should be possible to reduce [substandard care through]
educational efforts and increased awareness of risk factors”. .
61 JAMA 272 (1994), pp. 1851–1857.
62 Chief Medical Officer (Sir Liam Donaldson)
65
If most medical adverse events are the result of poor systems and training
and can be mitigated by better ones, that would be a start.
Together with the WHO the US and the UK are certainly at the vanguard
of the patient safety movement and UK patients will benefit from this at
some stage, it is hoped. There is little or no evidence of improvement as
yet partly because we do not yet have a reliable measure of the incidence
of medical adverse events.
.
8.2 The WHO’s World Alliance for Patient Safety
A major and heartening development over the last decade has been the
intervention of the WHO.
On October 27, 2004 WHO launched a World Alliance for Patient Safety
dedicated to bringing significant benefits to patients in countries rich and
poor in all corners of the globe.
The Alliance was established in response to Resolution WHA55.18,
approved by WHO’s 55th World Health Assembly in May 2002, which
urged member states to pay the closest possible attention to patient safety
and establish science-based systems for improving safety and the quality
of care. More information on the World Alliance is available at
http://www.who.int/patientsafety/en.
WHO Patient Safety has a Secretariat with a permanent staff of over 40
people who are based at WHO HQ and WHO Regional focal points.
Since the resolution was passed, WHO has established a number of work
programmes tackling systemic issues such as taxonomy (the science of
classification), estimating hazards, and the development of reporting and
learning systems. WHO has also brought together its technical experts in
areas such as blood safety, injection safety, drugs and medicines, making
pregnancy safer and medical devices, so that their individual expertise
can be harnessed to tackle global patient safety issues.
WHO Patient Safety has been responsible for a number of important
initiatives including the campaign for hand hygiene improvement “Clean
Care is Safer Care” and the Safe Surgery Saves Lives campaign. The
latter was discussed at para 4.6.3.
66
However success is elusive. Writing in the WHO Patient Safety
Newsletter63, Sir Liam Donaldson, Chair of WHO Patient Safety says,
after referring to early developments:
“Just over ten years later, we as a global community are still
struggling to explain to our patients and their families whether
health care is safer. This is in part because improving safety is
hard work. It involves changing ingrained behaviours, in
redesigning expensive medical technology and in realigning our
thinking to focus on systems. But this is only part of the reason.
Our inability to show the world where the dashboard of safety and
quality is going is also because we have not sufficiently advanced
the science of safety measurement.”
8.3 The Institute for Healthcare Improvement (IHI)
This independent not-for profit-organization based in Cambridge,
Massachusetts
“believes that everyone deserves safe and effective health care”,
and has
“been working with health care providers and leaders throughout
the world to fulfil that promise”.
IHI
“focuses on motivating and building the will for change;
identifying and testing new models of care in partnership with both
patients and health care professionals; and ensuring the broadest
possible adoption of best practices and effective innovations”64.
IHI has a staff of more than 100 people. It also has partnerships with
hundreds of faculties around the world who share what they know and
learn from each other.
IHI has a large and varied number of educational programmes, many
virtual or using remote learning techniques. It also has a number of
strategic initiatives in various countries, the UK, Denmark, three African
countries and various states in the USA.
63 Measuring the unmeasurable No 7, May 2011
64 IHI website accessed 13th July 2011
67
8.4 “Building A Culture Of Patient Safety” Report Of The Eire
Commission 200865
In January 2007 Mary Harney the Irish Minister for Health set up a
Commission on patient safety and quality assurance
“in order to develop clear and practical recommendations which
would ensure that the safety of patients and the delivery of high
quality health and personal social services would be paramount
within our health service.”
The problem in our neighbour Eire appears to have been similar to that in
the UK at least until this report. There is a sign that in the short time
since, at least in terms of a culture of openness, accountability,
organisation and management of patient safety, and systematic reporting
and analysis of medical adverse events, they may have turned a corner as
we saw in Para 4.9 above.
In the Foreword to the Report Dr Deidre Madden the chairperson said
eloquently:
“We are entitled to be partners in our own healthcare, kept
informed about our treatment and treated with honesty and respect
if something goes wrong.”
She went on to describe the aim of the Commission on Patient Safety and
Quality Assurance:
“ to provide recommendations for a framework of patient safety
and quality which will lead to effectively governed healthcare
facilities, increased involvement of patients and service users in
healthcare decision making at all levels of the system, and the
development of local and national leadership with clear
accountability and reporting relationships. The Commission’s
objective is to make recommendations for organisational,
regulatory and educational reform which will create a culture of
patient safety for our health system. Such a culture will drive
clinical effectiveness where best practice will be based on national
and international evidence, and audit will be the norm in every
healthcare facility and for every healthcare professional. A patient
safety culture will develop open communication with patients, and
ensure learning throughout the system when things go wrong.”
65 http://www.dohc.ie/publications/pdf/en_patientsafety.pdf?direct=1
68
The Executive Summary acknowledged the challenge:
“It is important to acknowledge that despite our best efforts,
medicine will never be a risk free enterprise. What we must do in
our efforts to make the system as safe as possible for patients and
staff is to ensure that we have the right checks and balances in
place to detect errant practices, identify and re-train clinicians
whose competence falls below appropriate standards, provide the
means by which to analyse and learn from mistakes when they do
occur and develop standards against which to measure the
competence of healthcare providers who seek to provide services to
the public.”
“The Commission agreed that the vision or framework around
which the Irish health system should be based is as follows:
Knowledgeable patients receiving safe and effective care from skilled
professionals in appropriate environments
with assessed outcomes.
The values underpinning this framework include openness, patient
centredness, learning, effectiveness and efficiency, good
governance, leadership, evidence-based practice, accountability
and patient/family involvement. In many of the reports surrounding
adverse events in Ireland and elsewhere, poor governance
structures have been identified as major contributory factors in the
analysis of how and why those events occurred.”
8.5 The National Practitioner Data Bank (NPDB)
The NPDB and the Healthcare Integrity and Protection Integrity Data
Bank (HIPDB) are information clearinghouses created by the US
Congress under the Health Care Quality Improvement Act of 1986.
The National Practitioner Data Bank (NPDB) is an electronic repository
of all payments made on behalf of physicians in connection with medical
liability settlements or judgments as well as adverse peer review actions
against licenses, clinical privileges, and professional society memberships
of physicians and other health care practitioners. By federal law,
information on all medical malpractice liability payments and on certain
adverse actions must be reported to the NPDB to improve health care
quality across the U.S on a nationwide (as distinct from individual state)
69
basis. It is a Federal Program. Collectively, the NPDB and HIPDB are
referred to as the Data Bank.
Together, the NPDB and HIPDB contain reports on health care
practitioners, providers, and suppliers, which are submitted by eligible
organizations as mandated by Federal law.
A centralized repository of information about disciplinary action
was viewed as the best means to facilitate timely and accurate
assessments of professional competence and to minimize the risk of
health professionals who are stripped of their practice privileges in
one state being able to simply move to another state and resume
practice without anyone knowing about the past professional
misconduct.66
The types of licensure actions and negative actions that must be
registered include criminal convictions, consent or disclosure violations,
misconduct or abuse, fraud, deception or misrepresentation, unsafe
practice or substandard care, improper supervision or allowing unlicensed
practice, improper prescribing, dispensing, or administering medication
or other drug violation.
The Data Bank is used to inform health care organizations - such as
hospitals, health plans, and health care regulatory entities (e.g., State
licensing boards) - that an in-depth review of a practitioner's past actions
may be prudent. Organizations use the Data Bank information along with
data from other sources when considering a practitioner for clinical
privileges, employment, affiliation, or licensure, or when reviewing a
practitioner's records.
The Data Bank may be accessed only by certain organisations such as
hospitals, state licensing boards and other health care organizations,
professional societies. Certain Federal agencies and others may query
and/or report to the Data Bank if they meet the eligibility requirements set
by law.
Hospitals are obliged to enquire of the Data Bank when physicians,
dentists, and other health care practitioners apply for medical staff
appointment (courtesy or otherwise) or for clinical privileges, and every
two years on physicians, dentists, and other health care practitioners who
are part of the medical staff or who hold privileges.
66 http://ushealthpolicygateway.wordpress.com/payer-trade-groups/l-health-care-regulation/health-professionalsregulation/national-practitioner-data-bank/
70
Practitioners, providers, or suppliers may access their own information.
Members of the general public may request data that does not identify
any particular organization or practitioner and Plaintiff's counsel and
plaintiff ay access information under certain limited conditions.
The NPDB Public Use Data File contains information on specific
variables taken from Adverse Action Reports and Medical Malpractice
Payment Reports received by the NPDB on licensed health care
practitioners, as well as information from reports of Medicare and
Medicaid exclusion actions.
9. PATIENT SAFETY IN ENGLAND
Introduction and government policy
It is impossible to speak of patient safety in England without first
acknowledging the pioneering role of AvMA,
AvMA was originally established in 1982 as 'Action for the Victims of
Medical Accidents' after strong public reaction to the television play
'Minor Complications', by AvMA's founder, Peter Ransley. In the play a
lady was injured by obvious gynaecological negligence. Her case failed
because of the total failure of the legal profession to mount such a case.
Persisting, calm and ever reasonable leadership was provided by its first
chief executive Arnold Simanowitz OBE. He was responsible for making
AvMA such an influence in patient safety and justice and supporting
thousands of injured patients and their families for over 20 years.
Arnold quietly coaxed a reluctant medical profession to the mirror so that
they could first recognise what may be occurring on their own patch.
The name was changed in 2003 to 'Action against Medical Accidents'.
Since its inception, AvMA has provided advice and support to over
100,000 people affected by medical accidents, and succeeded in bringing
about massive changes to the way that the legal system deals with clinical
negligence and in moving patient safety higher up the agenda in the UK.
In the publication in 2000 of OWAM (referred to in para 8.1 above) the
CMO for the DoH issued a wake up call regarding patient safety, to itself,
the NHS and the medical and allied professions as a whole.
71
“The Way Forward67
19 The time is right for a fundamental re-thinking of the way that
the NHS approaches the challenge of learning from adverse health
care events. The NHS often fails to learn the lessons when things
go wrong, and has an old fashioned approach in this area
compared to some other sectors. Yet the potential benefits of
modernisation are tremendous – in terms of lives saved, harm
prevented and resources freed up for the delivery of more and
better care.
20 We believe that, if the NHS is successfully to modernise its
approach to learning from failure, there are four key areas that
must be addressed. In summary, the NHS needs to develop:
_ unified mechanisms for reporting and analysis when things
go wrong;
_ a more open culture, in which errors or service failures
can be reported and discussed;
_ mechanisms for ensuring that, where lessons are
identified, the necessary changes are put into practice;
_ a much wider appreciation of the value of the system
approach in preventing, analysing and learning from errors.
21 Only if these four conditions are met can the NHS hope to
develop the modern and effective approach to learning from
failures that it so badly needs.
Since this publication in 2000 the DoH has made some effort to address
these areas and improve patient safety. This effort has been the subject of
a number of reports.
The National Audit Office (NAO) conducted a review on the
implementation of the Government’s policy on patient safety. In
November 2005 the NAO published its Report “A Safer Place for
Patients: Learning to improve patient safety”
The report acknowledged achievements but said that much had still to be
done. Key challenges identified included:
o “renewed strategies to encourage more open reporting of patient
safety risks and events by healthcare staff;
o more regular feedback from the NRLS, with regular publications to
the NHS, providing examples of learning from the data;
67 Executive summary
72
o stronger engagement of patients in identifying patient safety issues
and designing solutions;
o drawing more systematically on all available sources of
information for the investigation of deaths and serious harm,
and to ensure wider learning;
o providing more information to the public on Trusts’ compliance
with safety alerts and clearer criteria to evaluate how well
solutions have been implemented;
o establishing performance monitoring of Trusts’ safety
culture, incident reporting and dissemination of results of national
reporting back to Trusts, and effective feedback of lessons and
solutions to improve safety;
o and ensuring patient safety is a core part of professional training”.
In turn the DoH in December 2006 published “Safety First A report for
patients, clinicians and healthcare managers.” (Safety First)
It found
“patient safety is too often seen by NHS boards and managers as
not having the same priority as achieving financial and access
targets. The information collected through the national reporting
system is not yet effectively informing patient safety at the local
NHS level. Not enough has been made of opportunities for
achieving real ‘on the ground’ improvements across the NHS. The
role of the NPSA in harnessing the expertise and commitment of
other agencies involved in patient safety is unclear.”
As Parliamentary Under-Secretary of State in the Department of Health,
Lord Darzi was asked to lead a Review to determine the course of the
NHS over the decade ahead. He reported in June 2008. The process was
described as the “NHS Next Stage Review”.
Lord Darzi, in his interim report68, identified as one of the visions for the
NHS the proposition that it should be safe:
[The]NHS must be as safe as it possibly can be, giving patients and
the public the confidence they need in the care they receive.
Safety should be the first priority of every NHS organisation.
People rightly expect to receive the safest possible care and to be
confident that this will be the case.
68 Department of Health (October 2007) Our NHS, Our Future – Next Stage Review Interim Report.
73
In the final Darzi report69, he repeated the fundamental importance of
patient safety:
The first dimension of quality must be that we do no harm to
patients. This means ensuring the environment is safe and clean,
reducing avoidable harm such as excessive drug errors or rates of
healthcare associated infections.
Continuously improving patient safety should be at the top of the
healthcare agenda for the 21st century. The injunction to ‘do no
harm’ is one of the defining principles of the clinical professions,
and as my Interim Report made clear, safety must be paramount
for the NHS. Public trust in the NHS is conditional on our ability to
keep patients safe when they are in our care.
Safety is the responsibility of all staff, clinical and non-clinical.
In its July 2010 White Paper “Equity and excellence:
Liberating the NHS” (Equity) clear emphasis was again placed on safety.
“The Government’s objectives are to reduce mortality and
morbidity, increase safety, and improve patient experience and
outcomes for all:
....i.
A culture of open information, active responsibility and challenge
will ensure that patient safety is put above all else, and that failings
such as those in Mid-Staffordshire cannot go undetected.”70
On open information Equity was very clear:
“In future, there should be increasing amounts of robust
information, comparable between similar providers, on:
• Safety: for example, about levels of healthcare-associated
infections, adverse events and avoidable deaths, broken
down by providers and clinical teams”…..
Governments’ policy (or intention) has been clear and one might have
hoped for a revolution in patient safety. However the patient safety
investment to fulfil the policy has been woefully lacking.
69 Department of Health (June 2008) High Quality Care for All – Next Stage Review Final Report,
70 Executive Summary Paragraph 5: Improving healthcare outcomes: “Equity and excellence:
Liberating the NHS”
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_117794.pdf
74
The reports could not have been much clearer as to the priorities.
However the “challenges” listed as remaining in 2005 by the NAO appear
to us to be still present and may now honestly be regarded as failings.
Progress had been made with the NPSA but it appears to have relapsed as
will be seen in Para 9.2 below.
We will next attempt to very briefly point out some of the other
landmarks in the patient safety landscape in England. A number of other
bodies concerned with patient safety are referred to in Paras 10.1 - 10.18
below.
9.1 The Quality Care Commission (CQC)
A part of the NHS, the CQC is the ultimate recipient (via the NPSA) of
patient safety reports and Serious Incidents (referred to in paras 9.2 & 9.4
below) from NHS Trusts about incidents that affect the health, safety and
welfare of people who use services, including injuries to people. It clearly
may write to trusts who do not comply with patient safety alerts71 issued
by the NPSA. It has the power to investigate and did so for example, in
relation to the situation at The Mid Staffordshire NHS Foundation Trust
before the better known Francis Inquiry.
CQC’s primary role in hospital safety appears to be reactive rather than
proactive. Its “Strategy for 2010–2015” contains no apparent direct
clinical patient safety measures. Generally it appears more concerned
with care standards.
In equity CQC’s role was enhanced:
“We will strengthen the role of CQC as an effective quality
inspectorate by giving it a clearer focus on the essential levels of
safety and quality of providers. In relation to the NHS, CQC's
responsibilities will include:
Licensing - Together with Monitor, CQC will operate a joint
licensing regime, with CQC being responsible for licensing against
the essential safety and quality requirements. Where services fail to
meet these essential levels, providers will be subject to enforcement
action, including the possibility of fines and suspension of services.
71 Para 9.2 below
75
Inspections - CQC will inspect providers against the essential
levels of safety and quality. Inspection will be targeted and riskbased. CQC will carry out inspections of providers in response to
information that it receives about a provider…. Where inspection
reveals that a provider is not meeting essential levels of safety and
quality, CQC will take enforcement action to bring about
improvement.
9.2 The National Patient Safety Agency (NPSA)
In the 2002 predecessor paper the NPSA (founded in 2001 in response to
The CMO/DoH paper OWAM was welcomed but concern was expressed
about the small size of its budget.
In para 5.7 we noted NAO’s scathing evidence to the HSC for its 2008
report “Patient Safety” about the The NPSA’s National Reporting and
Learning System (NRLS).
“…….. patients may have died or suffered harm as a result of
incidents that could have been averted..….there appears to be
surprisingly little evidence of any significant learning coming from
the NRLS”
Although the NAO was not impressed by the NPSA’s cost efficiency we
wonder whether its failings partly flow from under funding and lack of
pertinent powers. It seems significant that so low was the reporting by
trusts of medical adverse events, that it was made compulsory, but only
nine years after their introduction.
The outcome of trust reports to the NRPLS is Patient Safety Reports
issued to trusts. These are analysed and lead to Patient Safety Alerts
issued to Trusts warning them of dangers arising.
Such are little more than the reports issued by the medical defence
organisations to consultants before 1990. The NPSA budget was £30.5m
in 2010/11. Its average permanent staff was 256 during this period72
although as we see later it may now be down to around 50 people.
In February 2011 AvMA published a report “Implementation Of
Patient Safety Alerts “Too Little Too Late?”” It is worth noting that
despite the NAO report’s recommendation (referred to in the Introduction
to Para. 9) that this information should be made more public, the data to
compile the report had to be extracted by a Freedom of Information
Request.
72 NPSA accounts 2010/11.
76
Summary Of Main Findings73
o “There were 654 instances of patient safety alerts which had not
been complied with. Whilst this represents a decrease of 50%
on the August 2010 figure, each alert not complied with means
that lives are being put at unnecessary risk. All alerts are
supposed to be complied with all trusts by the given deadline,
and trusts have been reminded of this requirement by the
Department of Health.
o 203 (50%) of trusts had failed to comply with at least one alert.
o 45 trusts had not complied with 5 or more alerts. 5 trusts had
not complied with 10 or more alerts.
o Many of the alerts which had not been complied with were
years past the deadline for completion. For example, “Safer use
st
of Injectable medicines” (deadline for completion 31 March
2008) had not been complied with by 26 trusts. “Right Patient
st
Right Blood” (deadline for completion 1 May 2009) had not
been complied with by 36 trusts.
o Even extra urgent “Rapid Response Alerts” had not been
complied with by many trusts. For example, rapid response
alert “Oxygen Safety in Hospitals” (deadline for completion
th
29 March 2010) had not been complied with by 31 trusts.
o Some trusts which had been amongst the worst performers in
our last two reports and to whom the Care Quality Commission
had been moved to write to remind them of the need to comply,
still have over 10 alerts outstanding. For example, Stockport
NHS Foundation Trust had 14 alerts outstanding (15 in
February 2010); Manchester PCT had 13 outstanding (23 in
February 2010); Barts and the London NHS Trust had 11
alerts outstanding (20 in February 2010); and Aintree
University Hospitals NHS Foundation Trust had 10 alerts
outstanding (12 in February 2010).”
73 AvMA website accessed March 2011
77
The NPSA is to be abolished by July 2012 following the Government’s
review of arm’s length bodies (ALBs) in July 2010. Its report,
“Liberating the NHS: report of the arm’s length bodies review”:
“highlighted the need to drive down administrative costs within the
NHS and outlined the Government’s intentions to reduce
bureaucracy, improve efficiency and streamline the functions of
both the Department of Health (DH) and its ALBs”.
The first division of the NPSA, Patient Safety, will move to the new NHS
Commissioning Board; the second, the National Clinical Assessment
Service, will become self funded; and the third, the National Research
Ethics Service, will be considered as part of the review of research
regulation. Confidential inquiries will be managed by the Healthcare
Quality Improvement Partnership.74
The proposed NHS Commissioning Board is intended to be the national
framework for the new GP Consortia that will replace Primary Care
Trusts.
The National Clinical Assessment Service supports the resolution of
concerns about the performance of individual clinical practitioners to help
ensure their practice is safe and valued.
The National Research Ethics Service protects the rights, safety, dignity
and well-being of research participants that are part of clinical trials and
other research within the NHS.
The NPSA currently manages three National Confidential Enquiries into
o Suicide and Homicide by People with Mental Illness
o Maternal and Child Health
o Patient Outcome and Death
Unsurprisingly there are divergent views about the step to abolish the
NPSA. Peter Walsh, chief executive of AvMA said:
"We are not interested in the ideology behind these reforms, but
are concerned about the potential impact on patient safety. The
National Patient Safety Agency, once the envy of the international
patient safety world, is already barely functional. There is no
coherent plan for patient safety in the transition period and no
74 After the abolition of the National Patient Safety Agency; John Scarpello; BMJ 2010; 341:c6076
78
clarity on how patient safety will be built into the new
arrangements.75”
Paul Burstow, The Minister of State, Department of Health made a firm
commitment to the Public Bill Committee of the House of Commons in
regard to:
“……..the important role that is currently discharged by the
National Patient Safety Agency. There is no difference between
either side of the Committee on the importance that the
Government attach to patient safety. We see that as a key priority
for all those working in the health service. We cannot allow patient
safety to be an add-on, or an afterthought. For that reason, the Bill
puts safety at the heart of the NHS and not at arm’s length, which
is how it is currently arranged.
Currently, the NPSA’s core function is to improve the safety of the
NHS by promoting a culture of reporting and learning from
adverse events. It does that primarily through the patient safety
division, which runs the national reporting and learning systems.
Functions of the organisation, while necessary in the system to
support wider quality and safety improvement, do not of themselves
need to be reformed at arm’s length from the Department. Safety is
a key domain of quality and will therefore be a central priority for
the commissioning board. Patients rightly expect that any service
provider within the NHS, and funded by the NHS, should be safe.”
……….Clause 19 inserts new section 13M in the National Health
Service Act 2006 to make provision to give the NHS commissioning
board responsibility for the functions currently carried out by the
NPSA: the collection of information about patient safety incidents,
the analysis of that information, and the sharing of the resulting
learning with all providers of NHS services—those who contract
with commissioning consortia, or directly with the NHS
commissioning board.
There is a notion that having those functions in a nominally arm’s
length body somehow makes them more effective than bringing
them right into the core of commissioning activity and leadership
within the system, which we think is a far more powerful way of
driving a safety agenda through the NHS…….
We now know of the power the national reporting and learning
system has for driving improvements in the safety of services; the
NPSA’s national reporting and learning system is the most
comprehensive system of its kind in the world, and we will preserve
75 The Independent 19/1/11
79
and improve on it. There is no intention for that system to be
jettisoned as part of the transition.
The….. impact assessment notes: the transfer of staff to the NHS
Commissioning Board will ensure that expertise in patient safety is
retained”76
It does seem however in practice that drastic reduction in provision is in
practice resulting. A telephone call to the NPSA established that
approximately 80% of the NPSA staff have left and will not be moving to
successor organisations.
We understand that no further Patient Safety Alerts have been issued for
some time. We are led to believe that it is envisioned by civil servants
that only a small fraction of the functions of The NPSA’s patient safety
division are to be assimilated within the new NHS Commissioning Board.
The NRLS’s “organisational feedback reports – FAQs” for March
2011contained the following Q&As77
When will the detailed organisational feedback reports be
available?
These reports will not be available for the fifth release of the
organisation patient safety incident data. However you will still be
able to access your earlier detailed reports.
Will I still be able to contact an NRLS Improvement Lead for
support?
Yes although we will not have sufficient resource in the future to
allocate a specific NRLS Improvement Lead to individual
organisations. You should email requests for support or
information via the Patient Safety Helpdesk.
The future of the NPSA’s functions in a cost cutting environment appears
to be in grave doubt.
9.3 Never Events
Never Events are serious, largely preventable patient safety incidents that
should not occur if the available preventative measures have been
implemented. They have been used in the NHS since April 2009. They
were voluntarily reportable by trusts to the NPSA but Never Events must
be reported to the NRLS from April 2010.
76 Hansard Thursday 31 March 2011
77 NPSA website accessed 27th July 2011
80
Trusts must immediately inform patients and/or their families that a
serious incident has occurred and offer support to patients/their families
and staff, and must discuss a possible “never event” with their
commissioners and, through the NPSA, report to the Care Quality
Commission.
Primary care trusts are required to monitor the occurrence of Never
Events within the services they commission and publicly report them on
an annual basis.
The DoH reported in October 2010 that the NPSA had received 111
voluntary never event reports for the year ending April 2010 at its
National Reporting and Learning System. Its report said never event
reports were spread throughout England, and occurred throughout the
year and across different trusts. One Nursing Times website reader
commented:“I am surprised it was only 110 reported never events. As with
most voluntary reporting schemes the reports probably only
represents the tip of the iceberg.”
Over half of the never events related to wrong site surgery. It has been
estimated that these 111 never events cost the NHS around £3.9million.
As specified in the operating framework for the NHS in England for
2010/11 with effect from April 2010, PCTs were expected to seek
recovery from the trust provider of the cost of the procedure/treatment
where one of the Never Events occurred.
There are since February 2011, 25 "never events" on the current list
published by the DoH. This includes the original eight events from
previous years, some of which have been modified. The list is as follows:
1. Wrong site surgery (existing)
2. Wrong implant/prosthesis (new)
3. Retained foreign object post-operation (existing)
4. Wrongly prepared high-risk injectable medication (new)
5. Maladministration of potassium-containing solutions (modified)
6. Wrong route administration of chemotherapy (existing)
7. Wrong route administration of oral/enteral treatment (new)
8. Intravenous administration of epidural medication (new)
9. Maladministration of Insulin (new)
10.Overdose of midazolam during conscious sedation (new)
11.Opioid overdose of an opioid-naïve patient (new)
12.Inappropriate administration of daily oral methotrexate (new)
81
13.Suicide using non-collapsible rails (existing)
14.Escape of a transferred prisoner (existing)
15.Falls from unrestricted windows (new)
16.Entrapment in bedrails (new)
17.Transfusion of ABO-incompatible blood components (new)
18.Transplantation of ABO or HLA-incompatible Organs (new)
19.Misplaced naso- or oro-gastric tubes (modified)
20.Wrong gas administered (new)
21.Failure to monitor and respond to oxygen saturation (new)
22.Air embolism (new)
23.Misidentification of patients (new)
24.Severe scalding of patients (new)
25. Maternal death due to post partum haemorrhage after elective
Caesarean section (modified)
9.4 Serious Incidents (SIs)
In March 2010 the National Patient Safety Agency launched a new
national policy for “Serious Incidents Requiring Investigation”. The
policy is embedded within the Care Quality Commission Regulation
Requirements and applies to all NHS providers and ensures national
consistency and clarification of roles. Trusts are required to report serious
incidents (SIs) to their PCT.
A final report is required for all SIs. The final report should follow the
NPSA root cause analysis (RCA) investigation report template and
include details of the RCA, lessons learnt, details of dissemination of
learning, and an action plan with recommendations, timescales and
responsibilities for action.
A serious incident requiring investigation is defined as an incident that
occurred in relation to NHS-funded services and care resulting in:
o Unexpected or avoidable death of [a] patient…..or
o Serious harm to [a] patient…..or where the outcome requires lifesaving intervention, major surgical/medical intervention,
permanent harm or will shorten life expectancy, or result in
prolonged pain or psychological harm
82
9.5 The NHS Institute for Innovation and Improvement (“NHSI”)
The NHSI has a number of programmes to help the NHS “make the
maximum impact in improving the quality and value of care for NHS
patients.”
Its website states:“The NHS Institute transforms good ideas into workable solutions
for an improving NHS.
In five years we have developed proven and effective products in
critical clinical areas which could save the NHS £6Bn.
At the NHS Institute: we are facilitators of change for
improvement, working alongside the frontline of the NHS
we are central to helping deliver quality and value to improve care
for patients and efficiency for the service
we interpret NHS policy change and work with local staff to
generate practical solutions
we are the NHS' own improvement agency, pioneers in effective
innovation, continually learning and translating great ideas from
other sectors
we understand the NHS because we are part of the NHS.”
One of NHSI’s programmes is “Quality, Innovation, Productivity and
Prevention” (QIPP). One of QIPP’s twelve workstreams is “Safe Care”.
Working with NHS staff this workstream aims to achieve:
o 80 percent reduction in hospital acquired pressure ulcers
(grade 3-4)
o 30 percent reduction in community acquired pressure ulcers
(grade 3-4)
o 50 percent reduction in catheter-acquired urinary tract
infections
o 25 percent reduction in falls in care
83
Safer Care programme
This is another NHSI programme.
The stated aim of the Safer Care programme is
“to build an NHS where every member of staff has the passion,
confidence and skills to eliminate harm to patients. Providing
education and training to build capability and capacity. Using
collaboration and partnership to generate the vision of an NHS
with no avoidable death or harm.”
NHS Institute for Innovation and Improvement is now a Special Health
Authority but as part of the re-organisation on 31/3/12 it is to become the
NHS Institute and will be part of DoH
9.6 The Patient Safety First Campaign 2008 -10
Patient Safety First sought to reduce harm to patients by changing
practise in specific areas, based on existing evidence. It was a two year
campaign launched as the UK’s part of the international move to make
hospitals safer. It had less than 15 full time employees and a budget of a
mere £1.5M. Its cause was 'to make the safety of patients everyone's
highest priority'. And its aim was 'No avoidable death, no avoidable
harm'.
It was jointly sponsored by the National Patient Safety Agency, the NHS
Institute for Innovation and Improvement, and The Health Foundation.
It continues in a virtual form hosting material for “Patient Safety Week”
and Matching Michigan a quality improvement project based on a model
developed in the United States which, over 18 months, saved around
1,500 patient lives. It largely relates to Intensive Care Units.
Patient Safety First’s website hosts a number of patient safety
improvement programmes and resources such as guides, videos, and case
studies.
One of its tasks was to help implement the Surgical Safety Checklist.,
another to create a strong organisational safety culture at trust board level.
In respect of the latter by the end of the two year campaign, 61% of acute
84
trusts had patient safety and quality as their first agenda item as distinct
from only 18% at the beginning.
9.7 The UK Health Foundation (UKHF)
UKHF has its roots in 1983 as the corporate charitable donations function
of a commercial private healthcare insurance company. On the sale of
that company it became in 1998 a significantly endowed, fully
independent healthcare charitable trust. The Trust was endowed with the
proceeds of the sale, amounting to some £540 million. It spends £25M
per annum on patient safety.
In England, in 2004, UKHF, together with the Massachusetts based IHI
launched the Safer Patients Initiative (“SPI”) to demonstrate that a wide
number of improvement tests in patient safety could be carried out
simultaneously and spread, and that organizational culture could be
transformed.
The first phase of SPI (launched April 2004 with four sites) aimed to find
practical ways of making acute hospitals safer for patients. Phase 2 began
in November 2006 with 20 additional sites. SPI demonstrated the health
service’s potential to ensure patient safety and has influenced national
safety initiatives across the UK.
Building on the success of the SPI, the Safer Patients Network (“SPN”)
was launched by The Health Foundation in June 2009, to find practical
ways of making UK acute hospitals safer for patients.
SPN links healthcare organisations that were part of SPI and aims to
create a self-sustaining member-driven community with participants
sharing best practice and developing new approaches to patient safety. It
is envisaged that the network will enable the community to test, develop
and export ways to make healthcare safer for patients by continuing to
build improvement skills in their systems of care.
9.8 Clinical Human Factors Group (CHFG)
CHFG is a small independent campaign group (registered as a charitable
trust) which aims to stimulate dialogue and demonstrate through concrete
85
action how a better understanding of the role of human factors can have a
significant impact on safety, quality and productivity in healthcare.
CHFG is a broad coalition of healthcare professionals, managers and
users of services who have partnered with experts in human factors from
healthcare and other high-risk industries to campaign for change in the
NHS.
Their vision78
“is of a healthcare system that places an understanding of human
factors at the heart of improving clinical, managerial and
organisational practice leading to significant improvements in
safety and efficiency. A safer, more reliable and efficient NHS will
remain a pipe-dream until we create a culture where human error
is seen as normal, inevitable and as a source of important learning.
We believe that for all serious failures of care, independent expert
investigation must become mandatory.”
We will refer further to the CHFG in the next chapter.
9.9 The General Medical Council
The GMC underwent some reforms in the late 1990s. Until then they
would rarely if ever even investigate patient safety issues as pertaining to
fitness to practice. Being unfit to practice was regarded as largely limited
to dishonesty and sexual behaviour with patients. By 2001 the GMC itself
noted
“it has been clear that the reforms already in place in the late
1990s were not sufficient”79
The GMC is a self regulating body of a profession struggling to keep up
with change. Barely surprisingly it finds it difficult to keep up.
The HSC decided to investigate the GMC and reported in February
201180. It decided that in the absence of a mechanism which made the
GMC effectively accountable they intended to exercise this function
themselves, on behalf of Parliament.
78 CHFG website: www.chfg.org accessed 2/8/11
79 http://www.gmc-uk.org/9_New_GMC_Overview_of_Reform.pdf_25398137.pdf
80 http://www.publications.parliament.uk/pa/cm201011/cmselect/cmhealth/557/55703.htm
86
The HSC then reported again on the GMC81 in July 2011. Included in its
conclusions are these damning remarks.
“1. Although, therefore, the Committee recognises that the GMC
achieves a high level of operational competence, it remains
concerned that the leadership function of the GMC within the
medical profession, and within the wider health community,
remains underdeveloped particularly in the areas of fitness to
practise, revalidation, education and training and voluntary
erasure.”
“12. Some of the decisions made by fitness to practise panels of the
GMC defy logic and go against the core task of the GMC in
maintaining the confidence of its stakeholders. Furthermore, they
put the public at risk of poor medical practice.”
Dame Janet Smith put her finger on the button, when she said in her letter
to the Secretaries for Health and Home Affairs82 when submitting her
Fifth Report on the Shipman Inquiry in 2004:
“However I have concluded that there has not yet been a change of
culture within the GMC that will ensure that patient protection is
given the priority that it deserves. I have been driven to the
conclusion that this is because the GMC is effectively controlled by
members elected by doctors. Many of the issues which the GMC
has to consider give rise to a conflict between the interests of the
profession and the public interest. Many members of the profession
expect the GMC to represent it rather than to regulate it in the
public interest.”
Precisely the same issues apply to the legal profession. This is why The
Legal Services Act 2007 stipulated that regulation of lawyers should be
clearly separate from representation and not prejudiced by
representational pressures. The same must apply to doctors. It helped the
legal profession recover some lost reputation and so it will the medical
profession.
9.10 The NHS Ombudsman
81 http://www.publications.parliament.uk/pa/cm201012/cmselect/cmhealth/1429/142907.htm
82 http://www.shipman-inquiry.org.uk/images/fifthreport/chapter/Fifth_Report_Covering_Letter.pdf
87
In June 2011 The HSC reported on its Inquiry into Complaints and
Litigation83. It found that the role of the Health Service Ombudsman
needs a complete overhaul if it is to provide an effective appeals process
for the complaints system.
Launching the report of its recent inquiry into complaints and litigation
against the NHS, Stephen Dorrell, Chair of the Committee said,
"The legal and operational framework of the Health Service
Ombudsman should be widened so that she can independently
review any complaint which is referred to her following
rejection by a service provider.
The Ombudsman's current terms of reference prevent her from
launching a formal investigation unless she is satisfied in
advance that there will be a 'worthwhile outcome'. We have
concluded that this requirement represents a significant
obstacle to the successful operation of the complaints system.
Patients should be able to seek an independent review of the
findings of internal reviews by care providers; the terms of
reference under which the Ombudsman works prevent her from
properly fulfilling this role. This needs to be changed."
The report's other key finding was that there continues to be unacceptably
wide variation in operation of complaints procedures within the NHS.
Commenting on this Mr Dorrell said:
"The Ombudsman's 2005 report "Making Things Better" called
for the establishment of clear national guidelines for the
handling of complaints within the NHS. Our Inquiry has
revealed that:
The NHS still has no national protocol for the classification and
reporting of complaints, and reporting by Foundation Trusts
remains voluntary
The government's recent consultation on information strategy in
the context of the Health & Social Care Bill did not mention
procedures for handling complaints
It remains unclear how patients’ complaints about services
delivered by primary care will be handled following passage of
the Health & Social Care Bill
NHS culture is too often defensive and the service remains to be
persuaded to adopt a more open culture.
83 http://www.parliament.uk/business/committees/committees-a-z/commons-select/health-committee/news/11-06-28-clreoprtsubstantive-/
88
9.11 Monitor
Monitor is the independent regulator of NHS foundation trusts.
It was established in 2004 to authorise and regulate NHS foundation
trusts. It is independent of central government and directly accountable to
Parliament.
There are according to its website three main strands to its work:
o determining whether NHS trusts are ready to become NHS
foundation trusts;
o ensuring that NHS foundation trusts comply with the conditions
they signed up to – that they are well-led and financially robust;
and
o supporting NHS foundation trust development.
In the 2010 white paper Equity, governance issues including safety, were
to be split between Monitor and CQC.
“s. Monitor will become an economic regulator, to promote
effective and efficient providers of health and care, to promote
competition, regulate prices and safeguard the continuity of
services.
t. We will strengthen the role of the Care Quality Commission as
an effective quality inspectorate across both health and social
care.”
“Providers will have a joint licence overseen by both Monitor and
CQC, to maintain essential levels of safety and quality and ensure
continuity of essential services.”
As part of the passage of the Health and Social Care Bill the current
government “paused, listened and engaged.” The NHS Future Forum
conducted this exercise and published recommendations. The
Government has now published its detailed response. The proposed
changes
“make it clear that Monitor’s role will be to put patients first and
to protect and promote their interests.
89
Monitor will be the overall sector regulator for health. Our core
duty will be to protect and promote patients’ interests. We will do
this by promoting the provision of care that is economic efficient
and effective. We will also ensure that quality is maintained and
where possible increased. This makes it clear that Monitor’s role
will be to put patients first and to protect and promote their
interests.
Monitor will retain the originally proposed functions on pricesetting and supporting the continuity of vital services in the event
of the financial failure, and its function of licensing providers
outlined in the original Health and Social Care Bill. We will also
make sure that competition is fair and operating in the interests of
patients and we will have a vital role in making sure that the
system works together to give patients choices about their health
and care. This means that we will tackle specific abuses and
restrictions that act against patients’ interests, to ensure a level
playing field between providers.
Monitor will continue to assess and authorise trusts as they seek to
become foundation trusts by 2014 and we will continue to obtain
assurance from the Care Quality Commission as part of the
authorisation process.”84
Now it seems that Monitor has a conflict of interests between safety and
economy: it is to put patients first and ensure that quality is maintained
and provide care that is economic and discharge functions on pricesetting.
9.12 The NHS Commissioning Board (NHSCB)
In Equity NHSCB was set to have five main functions
o national leadership on commissioning
o promoting patient involvement and choice
o development of GP commissioning consortia
o commissioning certain services (including maternity services)
o allocating and accounting for NHS resources:
none of which had any direct patient safety content. It was planned to set
standards for the quality of NHS commissioning (as distinct from acute
care performance), and:
84 Monitor website accessed 5/9/11: http://www.monitor-nhsft.gov.uk/home/about-monitor/monitors-proposed-new-role
90
“to avoid double jeopardy and duplication, it will take over the
current CQC responsibility of assessing NHS commissioners and
will hold GP consortia to account for their performance and
quality.”
The DoH has a Q&A page relating to the NHSCB on its website stating
“Subject to the passage of the Health and Social Care Bill, the
NHS CB will be established as an independent statutory body in
October 2012. It would then take on some formal statutory
accountabilities, including the authorisation of clinical
commissioning groups and the planning for 2013/14. The Board
would be fully operational by April 2013.”
It does appear from the same website that two thirds of the NHSCB’s
staff will be deployed locally within the ‘field force’ managing
relationships with clinical commissioning groups and performing direct
commissioning and other associated functions.
In July 2011 The NHS Chief Executive launched a paper “Developing the
NHS Commissioning Board”85. This provides that
“The leads for improving patient safety and patient experience
would report to the Nursing Director. The core role of the
professional leads would be to harness the different functions and
tools available to the Board (including commissioning, finance,
patient and public engagement, transformation….) to drive
improvements in outcomes.”
It appears to be planned to have one nursing lead working with one of 30
teams each of 30-40 people for patient safety.
Annex 1 Figure 1of the paper is The 2011/12 NHS Outcomes Framework
“One framework defining how the NHS will be accountable for
outcomes
Five domains articulating the responsibilities of the NHS
Ten overarching indicators covering the broad aims of each
domain”
The fifth Domain is:
“Treating and caring for people in a safe environment and protect
them from avoidable harm
85 http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_128196.pdf
91
Treating and caring for people in a safe environment
Overarching indicators
Three part measure patient safety measure consisting of:
5a patient safety incident reporting
5b severity of harm; and
5c number of similar incidents
Improvement areas
Reducing the incidence of avoidable harm
5.1 Incidence of hospital-related venous thromboembolism (VTE)
5.2 Incidence of healthcare associated infection
i MRSA
ii D Difficile
5.3 Incidence of newly-acquired category 3 and 4 pressure ulcers
5.4 Incidence of medication errors causing harm
Improving the safety of maternity services
5.5 Admission of full-term babies to neonatal care
Delivering safe care to children in acute settings
5.6 Incidence of harm to children due to ‘failure to monitor’
Whilst those are laudable aims it remains difficult to see that the new
body will either discharge the current functions of the NPSA or even
approach expanding them to the level we believe we have demonstrated
as necessary to begin to resolve the problem.
9.13 The Patient Safety All Party Parliamentary Group (“PSAPPG”)
The PSAPPG is one of many informal cross-party groups that are run by
and for Members of both houses of Parliament. The PS APPG was set up
to specifically address patient safety in the NHS. Its work is underpinned
by a core set of aims, to:
o examine issues concerning patient safety
o raise awareness of those issues among parliamentarians
o provide a forum for discussion and debate on key areas
affecting patient safety
o generate recommendations for the Government to improve
patient safety
9.14 Confused, Ineffective Governance
92
In Safety First (2006) the DoH cited frank and honest feedback it had
been given from within the NHS about the failure of governance efforts
to fully embed a patient safety culture in the NHS and said86
“Locally, awareness and commitment to patient safety among NHS
healthcare professionals is strong but engagement in the national
strategy is weak.
Significant confusion appears to exist amongst clinicians and
managers with regard to the role of functions of the NPSA and
other agencies that might be able to help them tackle safety issues.
Excellent and important projects have often failed to be sustained
and incorporated into lasting system improvements.
“The NHS is not on board.”
“Compared to the ambitions of OWAM, we have
not come as far as we should have.”
There does not appear to be a comprehensive and explicit
approach to patient safety in the NHS. There is a view that the
service either tackles patient safety in terms of narrow and specific
targets, e.g. reduction of MRSA infections, or it exists on the
periphery of provider organisations’ corporate or clinical
governance agenda.
“Patient safety… is higher up the local agenda than it was,
but is still one removed from mainstream business.”
“Patient safety has been somewhat overshadowed by
other pressures on the service and while the principles
are strongly supported, the service seems at a loss on
how to bring patient safety concepts to fruition.”
In the NHS Next Stage Review (Interim Report) in October 2007 Lord
Darzi might be taken as saying that largely governance problems had
significantly improved.
“Since then [2000], the NPSA has been established, along with
independent regulation underpinned by improved clinical
governance.”
Governance problems within the NHS as a whole were addressed by The
Francis Independent Inquiry into The Mid Staffordshire NHS Foundation
Trust (February 2010) chaired by Robert Francis QC (“the Francis
86 Paragraph 2.3 Moving from awareness to priority across the NHS
93
Inquiry”)87. Robert Francis QC well summarised the establishment of
clinical governance into the NHS since the second half of the 1990s.
“The concept of governance as it is now understood cannot be
described as new or as an esoteric matter known only to a few.”
That Inquiry found that:
“Whatever is done by way of governance it is important that
information derived about how the Trust and its staff are
performing is obtained by the Trust Board so that it can assure
itself that proper standards are being observed and inform itself of
the need to take corrective action”;
and that the earlier Health Care Commission investigation led it to write
to the Trust on 23 May 2008
“requiring immediate action to address its findings that:
... there appears to be an almost complete lack of effective
governance...”
The Inquiry noted evidence that:
… effective governance is the key to providing the best service and
ensuring patient safety, and that without good governance it is
quite impossible for a Board to be effective.
The Inquiry recommended88:
All NHS trusts and foundation trusts responsible for the provisions
of hospital services should review their standards, governance and
performance in the light of this report.
It is apposite here to observe that even from this brief overview of a few
of the systems and agencies in place (let alone the multiple sanctions to
which the medical profession maybe subject) there is a deal of
unnecessary complexity and confusion in clinical governance. There
already appears to be a degree of mission creep and confusion regarding
87 http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_113447.pdf
88 Ibid Recommendation 18:
94
the respective patient safety roles of Monitor and CQC as was apparent in
the Introduction to Para. 9.
In their evidence to the HSC referred to below and in Appendix 2, The
Clinical Human Factors Group (Para 10.3), the Health and Safety
Executive (Para 10.5), The Medical Protection Society (Para 10.6), and
the Quality, Reliability, Safety and Teamwork Unit, Oxford University
(QRSTU) (Para 10.9), variously criticized existing clinical governance
the former saying:
“governance structures were largely ineffective and should be
restructured, top down clinical governance didn’t work, there was
confusion and lack of training and skill.”
The HSC Patient Safety Report of 2009 concluded:
“The relationship between commissioning, performance-managing
and regulating bodies is not defined clearly enough. There are, as
Baroness Young put it, "a lot of players on the pitch” and we are
concerned that too often they are not an effective team. There is
evidence of overlapping functions and multiple submission of
information to different regulators. Most disturbing of all is that
Foundation Trusts appear to be operating in an entirely different
regulatory framework from non-Foundation Trusts.89”
10. THE HSC REPORT ON PATIENT SAFETY (PUBLISHED JUNE
2009)
Introduction
The HSC 2009 Report on Patient Safety does not make easy reading for
NHS patients. It is available online at
http://www.publications.parliament.uk/pa/cm200809/cmselect/cmhealth/
151/15102.htm
It is comprehensive, dealing with policy, incidence and (to a limited
extent) cost of medical adverse events, patient and family outcomes and
the whole raft of internal NHS bodies, patient safety work and issues, the
role of the DoH and Government, conclusions and recommendations.
89 Select Health Committee Report 2009, Patient Safety; Chapter 9 Commissioning, performance management and regulation;
conclusion para 262
95
Some of the evidence given to it is compelling and frank. It is worth
setting out but is extensive, and so important extracts are set out in
Appendix 2. That appendix is not intended to be a fair representation of
the totality of the evidence. For this it needs to be read in full. Some good
things are said about patient safety provision. Our purpose is to highlight
some of what was said about what still needed to be done. Regrettably, it
also has to be said, some of the evidence reads as narrative with variable
degrees of complacency.
To give a flavour of the contents of Appendix 2, brief excerpts are set out
below.
10.1 From a Memorandum by the Royal College of Opthalmologists:
“… for many years before [the year 2000] and most importantly
ever since then, NHS organisations have perpetuated a
performance management and target culture, rather than a safety
culture….
“..recent policy directions refreshing patient safety at conceptual
levels are welcomed. What are now needed are the resources and
clinical leadership to put these thoughts into action. The patient
safety mindset and memory is present, it now needs limbs.
Otherwise it is all talk and no action.”
10.2 From a Memorandum by the Health Foundation
“1.1 NHS care and treatment is replete with avoidable error. The
bulk of this is caused by system failure resulting in chronically
unreliable care delivery.
1.4 Other industries have seriously addressed safety and the same
can be done in the NHS.
10.3 From a memorandum by The Clinical Human Factors Group
“… members believe that the lack of HF training in medicine
means that patient care is more hazardous than it could and should
be.”
“2.1 Many safety-critical industries have reduced accidents and
harm by knowledge of error theory and HF principles. …..Systems
design and the appropriate training of staff assure safety.
96
2.2 Training in H[uman]F[actor] skills such as teamwork and
communication is virtually absent in healthcare. It should be
mandated by regulation, taught and examined.
2.3 Those who work together should train together. Research has
shown that teamwork training may reduce technical errors by 30 50%.
10.4 From a Memorandum by Guy Hirst and Trevor Dale that echoed the
last observations
“….we have observed numerous examples of less than effective
team working in the operating theatre. Such examples have the
potential to cause patient harm….
We believe that training of non-technical (teamworking) skills
should be introduced immediately at all stages of medical
education and across all disciplines…..
There are many NHS staff who recognise the problems and are
capable of suggesting solutions. They should be encouraged to
develop these solutions which would fit the culture prevalent within
their own Trust…..
Independent investigation of unsafe occurrences must be mandated
to avoid protectionism.”
10.5 From a Memorandum by the Health and Safety Executive (HSE)
“EXECUTIVE SUMMARY:
1. The Health and Safety Executive (HSE) has a wide-ranging statutory
role to regulate risks from work activities, this includes ………risks to
patient safety.
3. The current situation can lead to confusion for duty holders, inhibit
the establishment of improved management practices and is not
necessarily the most effective use of public resources. It is hoped that the
establishment of the new Care Quality Commission and its associated
provision of enforcement powers can be used to ensure more effective
regulation of patient safety.
10.6 From a Memorandum by the Medical Protection Society
97
3. A formal collaborative framework of bodies with interests
central to patient safety should be established. This structure
would act as a repository for lessons learned and from which best
practice could be disseminated.
5. Patient safety and risk management should be embedded within
the undergraduate and postgraduate curricula. Hospital induction
programmes should be mandatory for all new healthcare staff.
They should be consistent and comprehensive in content and
quality and should include training in clinical governance and risk
management.”
10.7 From a Memorandum by the Confidential Enquiry into Maternal and
Child Health (CEMACH)
— The role of national confidential enquiries could be more
closely integrated with the rest of the system for improving
patient safety.
— Specifically, they could be used to independently assess
whether the high standards of clinical care promulgated in
national clinical guidelines are applied locally.
— Further, higher priority should be attached to the new
national confidential enquiry into child health.
10.8 Memorandum by the Patient Liaison Group: Royal College of
Surgeons England
There may be many useful lessons that could be learned from the
experience and training carried out in other high-risk industries
such as the airlines and applied within surgery for example.
There is a need to change the culture to one where reflection on
practice is used to enhance learning and skills, rather than
encourage "blame".”
98
10.9 Memorandum by the Quality, Reliability, Safety and Teamwork
Unit, Oxford University (QRSTU)
1.3. Analysis of the causes of patient harm supports a model in
which defects in (a) staff communication culture, (b) systems of
work and (c) technology can combine unpredictably to cause harm.
1.8. We recognise the need for urgent action to improve the
current situation…. certain broad safety principles, already
capable of being enunciated and supported from current evidence
in healthcare and other industries, should be strongly
supported…..
1.9. We recognise that current clinical governance systems are
largely ineffective, and recommend that they are re-structured…..
10.10 From a Memorandum by the National Patient Safety Agency
(NPSA)
7. The top ten risks to patient safety are:
— Variable leadership from Boards, senior clinicians and senior
managers
— A blame culture which drives problems underground
— Defensive communication with patients and their families when
things go wrong
— Limited patient safety education for staff in their basic training
— Not enough emphasis on building high performing frontline
teams
— A reactive approach to risk meaning that hazards are not
identified before they lead to patient harm
— A superficial approach to incident investigation which often
fails to identify the underlying causes and system weaknesses
— Inadequate standardisation of equipment and processes
causing unsafe variability
99
— Patchy and slow implementation of safer practices in frontline
services
— Not harnessing technology as a powerful tool for protecting
patients against harm
10.11 From a Memorandum by the Medical Defence Union
— We recommend that members of the secondary and primary
care teams take part in regular systematic significant event audit
and that the results are collated regionally and on a national basis,
to identify potential risks to patient safety. Such information can be
shared with managers and clinicians to assist them to improve
patient safety.
— We recommend that complaints and claims data is pooled
across the UK. Details of the complaints and claims analysed and
risk management advice should be shared regularly with managers
and clinicians to assist them to make decisions and to inform their
practice.”
10.12 From a Memorandum by the Royal College of Nursing
1.7 …… The RCN has consistently made the point that regulation of
health and social care needs to be adequately funded.
1.9.1 … There is a real need to support staff to increase their
understanding of patient safety and devise ways of maintaining their
knowledge and skills over the course of their working lives.”
10.13 From a Memorandum by the Royal College of Midwives
1.3 The best way to improve safety from where we are now is to
investigate what goes wrong and attempt to stop such things
happening again.
1.4 Good work like this is being done, but the findings are not
always implemented.
1.6 We recommend midwifery representation on Trust Boards so
that issues of safety in maternity care can be raised at the highest
local level.
100
1.7 Finally, we must see vast improvements in the collection of
data. The current situation is very patchy. The Committee has
raised this before; it should raise it again.”
10.14 From a Memorandum by Action against Medical Accidents
…consolidation of the National Patient Safety Agency (NPSA) as
the key central organisation focussed purely on patient safety, and
more "clout" to be given to its alerts / guidance,
…more priority/resources being deployed to safety "solution" or
intervention work on known issues rather than making reporting
systems more elaborate,……….”
10.15 From a Memorandum by the Royal College of Pathologists
The single greatest improvement in patient safety in the area of
laboratory medicine would be the implementation of hospital-wide
(or UK-wide?) automatic identification systems (i.e. IT-linked
barcodes and/or RFID devices), applicable to patients, medicines,
procedures and investigations including radiology and laboratory
investigations. Many commercial organisations have implemented
systems of this sort,………. Why not the NHS?
10.16 From a Memorandum by the Council for Healthcare Regulatory
Excellence
— 3. The purpose of the regulation of health professions is to
protect the public and enhance public trust. ……………..The
work of the individual regulators in setting standards for health
professionals, maintaining a register of professionals, taking
action where a professional's fitness to practise has been called
into question,…….
10.17 From a Memorandum by the NHS Confederation
— A systemic approach to preventing, analysing and learning
from errors is essential to embed changes for patient safety.
— Leadership from the top is essential for promoting safety
cultures.
101
— The Care Quality Commission must take ownership of the
quality and safety agenda, and lead a co-ordinated approach to
ensuring patient safety.
— The role of commissioners in improving safety needs to be
clarified.
11. THE PSYCHOLOGICAL OR HUMAN FACTORS PERSPECTIVE
11.1 Introduction
It is hardly novel to observe that success in any complex professional
venture depends on more than one attribute. In the mix one would expect
to see technical skill and up to date knowledge, the ability to work
effectively with the people around one, (be they recipients of the service
provided, suppliers and colleagues with varying degrees of qualification),
good communication skills, and the ability to be a good team player.
The latter skills have been the subject of business and professional
training for approaching a century. Quality standards such as BS 5750
(1970’s) merged into ISO 9000 in 1987 and organisations like Investors
in People (1991) made it clear that non technical skills were there to be
acquired, could to a significant degree be taught and were essential for
success.
Medics, some more than others, require possibly more of these human
skills than many. An obvious characteristic of disgraced gynaecologists
Rodney Ledward and Richard Neale was their arrogance. Arrogance can
be found in anyone of course but it may be thought to be more florid in
some lawyers and doctors. Doctors make life and death decisions. At
least paternalism, seems to us to be an occupational hazard for doctors
such as surgeons and here lies a dichotomy.
Surgeons (for example), especially gynaecologists, spinal and
neurosurgeons and trauma surgeons do pretty amazing things in terms of
saving life. To do so must require extraordinary belief in one’s ability and
self confidence.
At the same time it is clearly important for doctors to understand that to
err is human, part of our condition and that in all probability they will err
professionally at some time, maybe with disastrous consequences. For
someone whose entire career is devoted to curing people and saving lives,
102
that stark contradiction seems one that needs addressing carefully, and at
the outset of training.
Human factors training is still comparatively rare.
Martin Bromiley, an airline pilot, Founder and current Chair of the
CHFG, writes on the CHFG website:
“In 2005 my late wife died as a direct result of medical errors
during an attempted routine operation. A subsequent independent
review identified that a well equipped operating theatre and a team
of clinicians all technically skilled had failed to respond
appropriately to an unanticipated emergency. They had failed to
follow protocols, use equipment properly, maintain situational
awareness, prioritise and make decisions appropriately.
Leadership was confused, communication problems arose despite
attempts to speak up by the team and any benefit of the team skills
and awareness present was lost. In short, human factors not
technical inability led to my late wife’s death.”
That last sentence merits a good deal of thought. Clearly Professors
Charles Vincent and James Reason agree with the principle, as do a
number of key clinicians and a few leaders in patient safety at DoH, who
support CHFG.
11.2Mid Staffs
Is pertinent here to refer to the conclusions of The Francis Inquiry.
This inquiry into the Mid-Staffordshire NHS Foundation Trust reported
in February 210 on concerns that at least 400 and possibly as many as
1200 patients may have died due to neglect and poor care.
Patients were left lying in soiled sheets, some so thirsty they drank water
from flower vases, with food out of reach and basic medical observations
neglected.
This is an extract from the letter from Robert Francis QC dated 5
February 2010 sending his Report of the Confidential Inquiry into Mid
Staffs to the Secretary of State.
“I think it is clear that my investigation has unearthed a
considerable amount of material that will be useful in helping
…………..the wider NHS, learn from the appalling experiences
suffered by such a large number of people………There can no
longer be any excuse for denying the enormity of what has
occurred. ……If there is one lesson to be learnt, I suggest it is that
people must always come before numbers. It is the individual
103
experiences that lie behind statistics and benchmarks and action
plans that really matter, and that is what must never be forgotten
when policies are being made and implemented.”
The following are all of the headings of the Conclusions Mr Francis
draws under a paragraph headed: What went wrong?
“A long-term failure; Problems identified but not addressed
effectively; Confused view of responsibilities; A lack of urgency;
Figures preferred to people; A lack of risk and impact
assessment; A focus on systems not outcomes; Those who received
care were not listened to; Staff disengaged from the process of
management; Insufficient attention to professional standards;
Lack of support for staff; A weak professional voice in
management decisions; A failure to meet the challenge of caring
for the elderly and the vulnerable; A lack of external and internal
transparency; False reassurance taken from external
assessments; A disregard for the significance of mortality
statistics.”
It is fair to say that this was a report as much about governance and
regulation as the standard of care, but it is interesting that poor clinical
judgement, lack of training and skill and so on are not mentioned.
The whole catalogue is of what might loosely be called human failings
rather than technical ones.
Similar issues are canvassed in the equally damning Health Service
Ombudsman’s Report delivered a year later, on the care of older people at
Para. 4.6.4.
11.3 The HSC’s Patient Safety Report Conclusions
There are many sources of evidence for the proposition that human and
managerial factors are key to patient safety.
The conclusions of the HSC’s Report on Patient Safety are full of
exhortations (a number of them reminders) relating to behaviour rather
than technical skill.
No attempt is made to set these out in full. They are not long and can be
found at the end of the report. Here we set out some extracts focussing on
the extensive work to be done largely in the context of non technical
issues.
“3. We are, however, concerned that Lord Darzi's emphasis on
quality and safety is an indication that, for all the policy
innovations of the past decade, insufficient progress has been made
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in making NHS services safer. We note that the report
commissioned by the Chief Medical Officer in 2006, Safety First,
concluded that patient safety was attaining a significant national
profile, but was "not always given the same priority or status as
other major issues such as reducing waiting times, implementing
national service frameworks and achieving financial balance".
This concern is heightened by the recent cases of disastrously
unsafe care that have come to light in a small number of Trusts.”
4. “………. Judging how far patient safety policy has been
successful requires more reliable data regarding how much
harm is done to patients. Unfortunately, neither the NPSA
nor the DH was able to provide us with that. Government
estimates of avoidable harm and the attendant financial
costs are extrapolations from old, very limited, data; and no
attempt has been made to produce reliable up-to-date
figures.”
5. We remind the Department of the value of the random
case note review that was a part of Royal College
inspections for accreditation for training of junior doctors.
We commend to all hospitals the practice of conducting
regular sample case note reviews, as is done at Luton and
Dunstable Hospital, to provide a clear indicator of local
performance in making services safer. We recommend that
the NPSA monitor progress by the NHS in improving patient
safety, using local sample case note peer review data and
other sources of information on harm to patients.
6. Harmed patients and their families or carers must receive
honest information, a full explanation, an unequivocal
apology and an undertaking that the harm done will not be
repeated. While, the NHS has made progress in this regard,
there is still too often a lack of frankness on all these counts.
9. The NHS continues too often to deal poorly with
complainants and fails to use complaints as a means of
improving services. We are sceptical that there will be a
major improvement following the latest in a protracted
series of changes to the complaints system.
13. The failure to be open and to satisfactorily address
complaints is in large part due to the fear of litigation. We
are appalled at the failure of the DH to implement the NHS
Redress Scheme three years after Parliament passed the
necessary legislation.
105
15. After the expenditure of much effort and funding on the
National Reporting and Learning System, clear progress has
been made in incident reporting; but we are concerned that
the NRLS is nevertheless still limited in its effectiveness.
21. Too often known patient-safety solutions fail to be
adopted in the NHS even when they are disseminated by
means such as Patient Safety Alerts. They are handed down
from on high as diktats (if they are passed on at all) without
frontline clinicians being convinced of their effectiveness.
Moreover, a culture persists in which various types of harm
to patients are seen as inevitable when in fact they are
avoidable if the right steps are taken.
22. Some organisations, however, have shown that it is
possible for improvements to be fully integrated in frontline
services by engaging and involving clinicians, and other
healthcare workers. The focus needs to be on tangible
improvements to health, drawing on staff's own initiative.
23. "Lean" thinking, using the initiative of frontline staff to
increase efficiency and use time more effectively, is
beginning to be introduced into the NHS through schemes
such as the Productive Ward programme and the Safer
Patients Initiative. This approach has much to commend it.
If less efficient ways of working can be eliminated then more
can be achieved and standards of care raised.
24. Lack of non-technical skills can have lethal
consequences for patients. However, the NHS lags
unacceptably behind other safety-critical industries, such as
aviation, in this respect. Human Factors training must be
fully integrated into undergraduate and postgraduate
education, as we discuss more fully below.
34. There are serious deficiencies in the undergraduate
medical curriculum, which are detrimental to patient safety,
in respect of training in: clinical pharmacology and
therapeutics; diagnostic skills; non-technical skills; and
root-cause analysis. These must be addressed…..Elements of
patient safety are taught, but this tends to be done implicitly
rather than explicitly; this should also be addressed in the
curriculum, which must make clear that patient safety is the
first priority of medical practice. Patient safety must also be
fully integrated into postgraduate medical education and
training as a core element, not an optional extra.
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35. Patient safety, including Human Factors, has yet to be
fully and explicitly integrated into the education and training
curricula of healthcare workers in general. This training
should include the recognition that errors will inevitably
occur in certain circumstances. There are convincing
arguments for interdisciplinary training to foster good
teamwork skills across professional boundaries: those who
work together should train together.
39……… Sustained improvement depends on releasing the
potential of staff to see, develop and own solutions.
41. We recommend the DH consider how to reinstate the
best aspects of the Royal Colleges' inspections in the new
system.
48. The DH should produce a succinct statement regarding
how commissioning, performance management and
regulation are defined, and how they (and the organisations
responsible for them) relate to each other.
49. There is disturbing evidence of catastrophic failure on
the part of some Boards in cases such as Maidstone and
Tunbridge Wells Trust and Mid-Staffordshire Trust. While
other Boards are not failing as comprehensively, there is
substantial room for improvement.
51. Many managers and non-executive members of Boards
with responsibility for patient safety seem to have little or no
grounding in the subject.
53. We commend to NHS organisations the measures
piloted as part of the Safer Patients Initiative to ensure that
Boards maintain safety as their foremost priority, namely
implementing tried and tested changes in clinical
practice to ensure safe care;
banishing the blame culture;
Providing the leadership to harness the enthusiasm of
staff to improve safety;
changing the way they identify risks and measure
performance, by using information about actual harm
done to patients, such as data from sample case note
reviews.
We strongly urge the adoption of these throughout the NHS.
107
54. In addressing the blame culture, we recommend that
Trusts use means such as the Texas Safety Climate Survey to
measure and monitor how far staff feel confident about
being open and reporting incidents.
55. We strongly endorse the DH's view that no Board in the
NHS should always be meeting behind closed doors. We
urge the Government to legislate as necessary to ensure
Foundation Trust Boards meet regularly in public; the
public should only exceptionally be excluded.
56…………We recommend that Annex 1 of the Health
Service Circular, HSC 1999/198, "The Public Interest
Disclosure Act 1998—Whistleblowing in the NHS" be recirculated to all Trusts for dissemination to all their staff as
a matter of urgency.
58……………From now on, all Government policy in respect
of the NHS must be predicated on the principle that the
Service's first priority, always and without exception, is to
ensure that patients in its care do not suffer avoidable harm.
The Government should state clearly that safety is the
overriding priority of the NHS and that, if necessary, other
targets should be missed where patient safety is being
jeopardised; for example, A&E patients should not be moved
to unsuitable wards just to meet the four-hour maximum
waiting target.
59. The key tasks of the Government are to ensure that the
NHS:



develops a culture of openness and "fair blame";
strengthens, clarifies and promulgates its
whistleblowing policy; and
provides leadership which listens to and acts upon
staff suggestions for service changes to improve
efficiency and quality and, by the provision of
examples and incentives, encourages and enables staff
to implement practical and proven improvements in
patient safety.
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In addition, the Government should examine the contribution of
deficiencies in regulation to failures in patient safety.”
11.4 The academic view
Since the relatively recent initiation of the process of self examination,
the medical profession as a whole is beginning to move away from
denial, burying its institutional head in the sand and finding some
conclusions that one senses are surprising them in terms of the causes of
medical error and the solutions.
“The organizing principle is that the cause [of medical adverse
events] is not bad people, it is bad systems. This concept is
transforming; it replaces the previous exclusive focus on individual
error with a focus on defective systems. Although the major focus
on patient safety has been on implementing safe practices, it has
become increasingly apparent that achieving a high level of safety
in our health care organizations requires much more: several
streams have emerged. One of these is the recognition of the
importance of engaging patients more fully in their care. Another
is the need for transparency. In the current health care
organizational environment in most hospitals, at least six major
changes are required to begin the journey to a culture of safety: 1.
We need to move from looking at errors as individual failures to
realizing they are caused by system failures; 2. We must move from
a punitive environment to a just culture; 3. We move from secrecy
to transparency; 4. Care changes from being provider (doctors)
centered to being patient-centered; 5. We move our models of care
from reliance on independent, individual performance excellence
to interdependent, collaborative, interprofessional teamwork; 6.
Accountability is universal and reciprocal, not top-down.” 90
Understanding
Error reduction begins, not with exhortations to take greater care,
but with understanding what human error really is, and above all,
the conditions which provoke it. This awareness is the only sound
foundation for the long term organisational, cultural and personal
90 Errors in Laboratory Medicine and Patient Safety; Lucian L. Leape; Clinica Chimica Acta Volume 404, Issue 1, 6 June 2009,
Pages 2-5
109
changes essential to reducing our own vulnerability, and its
potential consequences.
What Program Research Suggests
Discussions with and hospitals and other healthcare institutions
reveal a wide diversity of patient safety initiatives. Most of those
encountered had their genesis in bad events of the recent past.
Though this approach provides a measure of protection against the
same thing recurring, it may offer little defence against other kinds
of hazard to patient safety. To achieve that, a comprehensive proactive approach to error management is needed.91
Once again we find it is the human or psychological factors much more
than just implementing safe clinical practices, that are required.
11.5 Surgical Safety Checklist.
We saw in paragraph 4.6.3 above how this almost halved the number of
deaths in surgery. What is this wondrous life saver? It’s a 19-item
checklist designed to improve team communication as well as
consistency of care. The checklist identifies three phases of an operation,
each corresponding to a specific period in the normal flow of work:
Before the induction of anaesthesia, before the incision of the skin and
before the patient leaves the operating room. In each phase, a checklist
coordinator must confirm that the surgery team has completed the listed
tasks before it proceeds with the operation. The list includes such basic
issues as:
“patient has confirmed
• identity
• site
• procedure
• consent
Surgery site marked and
anaesthesia safety check completed” (all before induction);
“confirm all team members have introduced themselves by name
and role
91 Professor James Reason: Delivering Patient Safety at http://:www.errormanagement.co.uk/
110
surgeon, anaesthesia professional and nurse verbally confirm
• patient
• site
• procedure” (all before incision)
And finally (before leaving theatre) –
“surgeon, anaesthesia professional and nurse review the key
concerns for recovery and management of this patient.”
“The mean (SD) number of communication failures per procedure
declined from 3.95 (3.20) before the intervention to 1.31 (1.53)
after the intervention (P < .001).”92
Once again we see it’s about communication and consistency so that
when professionals work in different teams, things are done in the same
way. It’s not only about professional technical skill.
A related study at The John Radcliffe Hospital in Oxford confirmed the
same trend.
“Unintended harm to patients in operating theatres is common.
Correlations have been demonstrated between teamwork skills and
error rates in theatres. This was a single-institution uncontrolled
before–after study of the effects of “non-technical” skills training
on attitudes, teamwork, technical performance and clinical
outcome in laparoscopic cholecystectomy (LC) and carotid
endarterectomy (CEA) operations. The setting was the theatre suite
of a UK teaching hospital. Attitudes were measured using the
Safety Attitudes Questionnaire (SAQ). Teamwork was scored using
the Oxford Non-Technical Skills (NOTECHS) method. Operative
technical errors (OTEs), non-operative procedural errors
(NOPEs), complications, operating time and length of hospital stay
(LOS) were recorded. A 9 hour classroom non-technical skills
course…… was offered to all staff, followed by 3 months of twiceweekly coaching from CRM experts. Forty-eight procedures (26
LC and 22 CEA) were studied before intervention, and 55 (32 and
23) afterwards.
Non-technical skills and attitudes improved after training
(NOTECHS increase 37.0 to 38.7,…. SAQ teamwork climate
increase 64.1 to 69.2,…..
92 ‘Evaluation of a preoperative checklist and team briefing….to reduce failures in communication’. L Lingard et al, Archives of
Surgery, 2008; 143(1): 12-17
111
OTEs declined from 1.73 to 0.98…., and NOPEs from 8.48 to 5.16
per operation…. These effects were stronger in the LC group than
in CEA procedures. The operating time was unchanged, and a nonsignificant reduction in LOS was observed. Non-technical skills
training improved technical performance in theatre, but the effects
varied between teams. Considerable cultural resistance to
adoption was encountered, particularly among medical staff.
Debriefing and challenging authority seemed more difficult to
introduce than other parts of the training. Further studies are
needed to define the optimal training package, explain variable
responses and confirm clinical benefit.93
This is hardly news in the medical profession. This next publication, in
the BMJ, of the views of medical staff was 11 years ago.
Pilots and doctors operate in complex environments where teams
interact with technology. In both domains, risk varies from low to
high with threats coming from a variety of sources in the
environment. Safety is paramount for both professions, but cost
issues can influence the commitment of resources for safety efforts.
Aircraft accidents are infrequent, highly visible, and often involve
massive loss of life, resulting in exhaustive investigation into
causal factors, public reports, and remedial action. Research by
the National Aeronautics and Space Administration into aviation
accidents has found that 70% involve human error.
In contrast, medical adverse events happen to individual patients
and seldom receive national publicity. More importantly, there is
no standardised method of investigation, documentation, and
dissemination. The US Institute of Medicine estimates that each
year between 44 000 and 98 000 people die as a result of medical
errors. When error is suspected, litigation and new regulations are
threats in both medicine and aviation surveys confirm that pilots
and doctors have common interpersonal problem areas and
similarities in professional culture.
In response to an open ended query about what is most needed to
improve safety and efficiency in the operating theatre, two thirds of
doctors and nurses in one hospital cited better communications.94
93 Improving patient safety through training in non-technical skills, Flin et al Qual Saf Health Care 2009;18:109-115
94 On error management: lessons from aviation; Robert L Helmreich; BMJ 2000; 320 : 781
112
11.6 Conclusion
The accepted view has been for a while now that medical adverse events
can be reduced and the health of the nations improved (in some cases
dramatically) not by the expensive drugs or staggering advances in skills
and technology but by what are called human factors that include good
old communication skills, in which we may have become poorer. As we
will see more in the next chapter, the medical profession have not been
quick to universally act on this self evident truth.
What it says to us is that the imperative for solving this modern scourge,
this wholesale slaughter of good men, women and children, does not have
to remain in the hands of the medical profession who have proved so
inept at curing themselves of this ill that is iatrogenosis.
Rather they need help from professionals in entirely different disciplines.
12. THE CASE FOR RADICAL REFORM
12.1 Introduction
We wish to emphasize our support for the medical profession. The
overwhelming majority of its members are highly skilled, dedicated and
industrious. They remain however, human and so may err. Over the last
half century enormous advances have been made in man’s ability to
survive illness and injury. One only needs to think of Arizona
Congresswoman Gabrielle Giffords who was shot in the head, the bullet
passing through the left side of her brain - from back to front early in
2011. Eight months later, she smiled at her friends as she attended to vote
in Congress.
Looking at medical advances holistically, in the context of the
Hippocratic oath and the shocking adverse event rate, these extraordinary
advances and benefits for mankind have come at an incalculable financial
cost and a high human price for many.
Has the pace of advance has been too great? Have we allowed the time to
sit back and review progress? Perhaps no cost benefit analysis has been
done along the way.
Take surgery as an example. We have discovered, only since the
introduction of the Surgical Safety Checklist, that surgery could have
113
been performed over the last half century, with nearly half the fatalities
from medical adverse events.
Safer surgery was possible with skills man has had for centuries. Should
we identify & tell the mothers and fathers, the children, the husbands the
wives the siblings of those who lost lives for the want of a checklist? No
one would be more delighted than doctors and nurses if medical adverse
events: this toll of death and injury were to be reduced.
However it is crystal clear from the research cited here that as high risk
professionals, medics and nurses do have a need to acquire skills (in
which they are not trained) often found absent: in particular human and
communication skills. Resistance to change is a well recognised problem
for many people. There have been volumes written about it. Possibly for
some perfectly natural reason that drew them to the profession in the first
place, lawyers and doctors may not naturally be at the head of the queue
as zealous reformers. We see evidence of this in Para 12 below.
There has certainly been a great deal of planning and individual effort put
into making patients safer over the last decade but we share the
conclusion of the HSC that there is little evidence of an overall
improvement.
We do not find that too surprising at all. A century or so of very rapid
advance with insufficient attention to patient safety along the way has
resulted in a backlog of accidents waiting to happen. . It has left an
unacceptable, very high toll of death and catastrophic injury. ’Much of
the problem is systemic, organisational and the stuff of ordinary human
frailty.
It must be stopped now. This generation of politicians may be judged, not
on how well it manages the current financial crisis but on whether it
continues to ignore the carnage we inflict accidentally in healthcare for a
want of investment in safety.
A sizeable step advance is required; a very significant investment indeed;
a new approach on a scale not hitherto seriously contemplated.
We have 3 matters to consider before proceeding to a conclusion:
o can the present regime of regulation be relied on to resolve this
crisis alone?
o is there a duty to make a greatly enhanced effort?
o is there a reasonable prospect of success?
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12.2 Can the present regime of regulation be relied on to resolve this
crisis alone?
We have seen from the remarks of the HSC, CHFG and others that the
medical profession needs help from outside agencies. Professionals with a
proper grounding in principles of safety, trained human factor specialists
and others are needed to work with the profession.
The investment in patient safety, whether in money, time or trouble has
been pitiful. This point was made in the predecessor paper. The NPSA
budget was a pathetic £30.5m in 2010/11. The actual spend in 2011/12 is
likely to be less than that, given its abolition. Of course there are some
other DoH initiatives but none of them are likely to exceed the NPSA
figure. £100M is likely a very generous estimate of the overall investment
specifically in patient safety.
The UK Health Foundation a charitable trust invests £25M pa in patient
safety.
In a real sense the health sector has a conflict of interest with the
fundamental change that is needed to make healthcare safer. As we will
see in the next paragraph it is they who have to undergo the change and
the loss of control (of self regulation), not something they will enjoy, one
suspects. Can they be expected to impose this pain upon themselves?
To see whether self regulation, and current government regulation is
working for patient safety we look at a few of the patient safety changes
that are (and have been) in the process of being introduced in a nonchallenging gradual manner into the health sector and its reaction to, and
performance against the clear need for, such change.
12.2.1. Learning from mistakes
As Professor Charles Vincent told us in Para 5.5 “In contrast” [with most
high risk industries], “learning within the health care sector, with some
notable exceptions, has generally been fragmentary and uncertain.”
We’ve just seen (in para 9.2) that even before its recent decline the NPSA
could not convince a significant minority of NHS trusts (20%) to comply
with 5 or more patient safety alerts, most of those being issued years
previously.
115
Lately even our prized learning system the NRLS is grinding to a halt. It
no longer has the staff to issue Patient Safety Alerts. There seems little
point in collecting medical adverse event data if it is not acted upon first
by issuing alerts and next by all trusts acting upon them.
Even when Patient Safety Alerts were being issued there was no system
for monitoring implementation of alerts, or of intervening with NHS
trusts who had not implemented required actions from patient safety
alerts (even those with large numbers of outstanding alerts and alerts
which are years past the deadline).
Neither was there a robust system for checking that NHS trusts who
declare themselves as being compliant actually were.95
The problem with the NPSA was that it had no teeth. Its lack of teeth
prompted:o its failure to collect from practitioners more than a fraction of the
medical adverse events occurring (para 4.4 above)
o the trusts continued failure to achieve compliance from trusts with
the patient safety alerts (para 9.2)
In the NHS Commissioning Board (NHCB) the NPSA will be a very
small toothless fish in a much bigger pond concerned largely with
commissioning and negotiating with trusts as providers. The NHCB has
not yet been created and when it is will take time to find its feet even in
its principle role. The prospect of a body concerned largely with General
Practitioners reforming their acute care colleagues’ technical or other
professional failures anytime soon is frankly absurd.
A short review may be helpful of the occasions where we’ve seen
repeated references to learning from mistakes.
o In 2000 OWAM the CMO’s report said in its Para 19 the time was
right for a fundamental re-thinking of the way that the NHS
approaches the challenge of learning from adverse health care
events.. the NHS often fails to learn the lessons when things go
wrong
o In OWAM’s Para 20 the CMO laid out four key areas that must be
addressed
95 AvMA Report – see Para 9.2
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o Paul Fenn’s observation (Para 7.4.2) that each litigation claim is
potentially a signal to health sector risk managers of where they
might look for improvements seems to have gone unheeded.
o The NAO testified (Para 5.6) that there was surprisingly little
evidence of any significant learning coming from the NRLS
o The Health Service Ombudsman told us (Para 4.6.4) an impetus
towards real and urgent change, including…. learning from
mistakes is needed.
o In November 2005 NAO Report “A Safer Place for Patients:
Learning…” (Para 9 Introduction) referred to the 7 key challenges,
reinforcing OWAM’s message about the four key areas.
o The NHS Federation (Para 10.18) again called for a systemic
approach to learning from errors.
o The Francis Inquiry 2010 (Para 12.2.4) reminded us that
complaints provide a valuable source of learning.
o The HSC in its 2009 Patient Safety Report said (its Para 15) that
the NRLS is limited in its effectiveness and
o Para 9 ibid that the NHS continues too often to deal poorly with
complainants and fails to use complaints as a means of improving
services. They were sceptical that there will be a major
improvement.
So that the deaths and injuries are not still in vain, so that families can be
told it really will not happen again, the NHS must learn now from at
least:
o
o
o
o
o
o
o
Every death
Every serious injury and serious near miss
Every claim
Every complaint
Every police, HSE and Coroner’s investigation and conclusions
Every report to the NRLS
Every ICD 10 Classification Y40-Y84 – [these must be completed
in more than the current 0.4% of cases]
It must be clear that many patients have died and many others suffered
harm as a result of the want of an effective national reporting and
learning system. Real and urgent investment is badly overdue here. Sector
wide systemic co-ordinated effort must take place here.
12.2.2. Should we employ doctors who are unable to speak English to
work in the UK?
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This question is still evidently troubling the GMC.
“Medics are allowed to work even if they speak as little English as
many Britons speak Chinese, the chairman of the British Medical
Association (BMA) suggested.
He called for tighter regulations to prevent a repeat of the death of
David Gray, a pensioner who died after he was treated by a
German visiting doctor working his first shift in Britain.
An inquest into the death found that the medic, Dr Daniel Ubani,
gave 70-year-old Mr Gray up to 20 times the recommended dose of
the drug.
Dr Ubani had previously failed an English test when applying to
work in Leeds, but was still allowed to work in the NHS in
Cambridgeshire….
He said: “We seem to be able to do little or nothing to check that
doctors from overseas – especially from Europe – meet the proper
standards of language and competence.”
Although Britain had benefited “enormously” from foreign doctors
over the years, he said that the case of Mr Gray “has shocked us
all”.
………..Although health Trusts can carry out individual tests, MPs
warned earlier this year that such checks were patchy.
Niall Dickson, chief executive of the GMC, has previously said that
the organisation is “extremely concerned that the current
arrangements do not provide patients with the protection they
need".
Andrew Lansley, the Health Secretary, said: "We are working
closely with the GMC to ensure that foreign healthcare
professionals are not allowed to work in the NHS unless they have
proven their competence and language skills, and we are currently
exploring a number of options to put a stop to foreign doctors
slipping through the net.”96
This is not a novel or difficult problem. It is conventional to interview
staff before employing them. The meeting will reveal whether the
96 www.telegraph.co.uk/health 10/6/10
118
interviewee has a good command of the English language. If there is
doubt a test is administered. If those skills are required (as here), but
absent the applicant is removed from the shortlist.
But 9 months after coming into the public arena as a major scandal, and a
year or more after warnings by MPs, and 3 years after Mr Gray’s death
from a medical adverse event we still read:
“The General Medical Council said current European rules
represent a “serious cause of concern” and risk to patient safety
by banning it from testing GPs’ language skills before they can
start working here.
The regulator said it has some doctors on its books who "are not
able to communicate in English" but could not prevent them
seeking work here under European law.
The GMC said it has already carried out fitness to practise cases
in which doctors have been struck off or suspended partly as a
result of their poor English.
In one case, a doctor was found “apparently speaking in a foreign
language” in an operating theatre, leaving the assistant surgeon
“unsure what assistance was required”97.
Technically the entirety of the problem seems to be simply that the
regulator itself can not test the English skills of doctors registered by
other countries’ regulators in the EEC. Therefore the regulator cannot
assume that a job candidate with an EEC registration speaks adequate
English. So it is left to the employer NHS trust to establish – as one might
have imagined in the first place.
The HSC commented on this in their July 2011 report on the GMC98.
“The GMC needs, as matter of urgency, to do more to understand
the risks associated with overseas-qualified doctors. It should offer
timely induction and needs to assure itself that those doctors in
peripatetic locum positions are adequately supervised and
supported. If a doctor is not safe to practise in the UK then the
GMC must ensure that they do not do so.”
97 www.telegraph.co.uk/health 31/3/10
98 For a link to this report see footnote 81
119
The overarching problem of doctors failing in one place and moving to
fail in another is not new. Richard Neale killed patients in medical
adverse events in British Columbia then Ontario (where he was struck
off, as our GMC was contemporaneously informed), and then did the
same in Northallerton in North Yorkshire before “gagging” his employer
there and going on to practice in an unsafe manner in Leicester and
London until he was finally struck off by the GMC in 2000.
That MPs have to warn of this language problem and the GMC has had to
bring a number of fitness to practise cases in which doctors have been
struck off or suspended partly as a result of their poor English speaks
volumes about the employing trusts’ utter lack of patient safety priorities.
If trusts are not capable of discharging this basic employer’s function and
the GMC has not cracked this problem of migrating dangerous doctors
then neither are fit for the purpose of ensuring patient safety.
12.2.3. Revalidation
It must stand to reason that a doctor like any other professional may
become unfit for any number of reasons from, life changing events (such
as divorce, illness or serious accident) or failing in the need to keep up to
date. Equally obvious is that in the case of doctors, unfitness to practice
will have (and has had) a deleterious effect on patient safety. It was under
public pressure in the wake of a number of medical scandals including
Shipman that the GMC decided to implement a scheme of revalidation of
doctors.
Professor Lesley Southgate, of University College, London, told the
Shipman Inquiry99
“There are poorly performing doctors out there who are harming
patients.”
Estimates as to the number of these doctors ranged between 3 and 10 per
cent. Sir Donald Irvine, a past president of the GMC, is reported to have
said of this figure (as applying to GPs),
"This means several million people are put at avoidable risk
without even knowing it. Looked at through patient's eyes, this is
simply unacceptable. On any terms, it is morally indefensible.”100
99 Chapter 26 Fifth Shipman Inquiry http://www.shipman-inquiry.org.uk/5r_page.asp?id=4805
100 http://www.independent.co.uk/opinion/commentators/shipman-hasnt-ended-the-betrayal-of-patients-485995.html
120
However progress with regard to revalidation was less than satisfactory
prompting Dame Janet Smith chairing the Shipman Inquiry to comment
on the current GMC proposals in her Fifth Report in 2004:
“Thus, the bottom line is that a doctor will fail to be revalidated
only if his/her professional performance is ‘remarkably’ poor. I do
not think that this is a satisfactory state of affairs.”
Yet we find that the process of revalidation is still not welcome in the
medical profession as an aide to patient safety.
“Speaking at the launch of a consultation document on the
revalidation of doctors [a renewal of a doctor's licence to practice
every five years], General Medical Council (GMC) chief executive
Niall Dickson said he thought ……….."quite a significant number
of doctors who haven't really applied their mind to it and have
heard this buzzword following around the profession for too many
years". These doctors worried that revalidation might be too
costly, too bureaucratic, too time-consuming and possibly unfair,
and would need reassurance.
The last group, which he did not think was very large, were
"inherently hostile maybe because they are concerned about their
own practice or think 'this is nobody's business and what I do is
fine and why should anybody come along and check it?'". That
group will be harder to convince, he said”.101
Perhaps we can thus see how this change (now expected to be rolled out
in 2012) has taken so long. For many years before Dr Harold Shipman
was arrested in 1998 the debate has rumbled on in the medical profession.
The fifth report of the Shipman Inquiry in 2004 pulled no punches on the
issue and even then the GMC did not roll out a consultation of the
profession until 2010.
In 2010 the GMC struck off or suspended for up to one year a total of 179
doctors - 0.07 of the total. This doesn’t seem to begin to address the
problem of 3-10% of doctors out there who are harming patients.
Approaching 40% of UK doctors are trained abroad. The UK reliance on
foreign doctors goes back to the 1970s. Foreign doctors naturally do not
know how the NHS works. There is a different cultural, ethical and
101 The Guardian 1/3/10
121
professional environment in the every country including the UK. The US
requires UK trained doctors to retrain for 3 years after taking the US
medical exam taken by all US trainee doctors.
The GMC has recently announced it is planning a basic induction
programme for all foreign doctors to help them understand how
healthcare is practised in the UK. Whilst this is welcome, one questions
why this was not implemented decades ago.
The HSC has been concerned about the delay and decided to undertake a
brief inquiry into the reasons for slow progress, the measures that were
being proposed and the reaction to them. In its brief February 2011
Report102 it said:“This consultation was the latest round of a discussion of this
subject which has now been going on for over ten years…. The
Committee does not regard this as an arcane matter; it goes to the
heart of the status of the medical profession as an independent
profession which is responsible for setting and applying its own
standards. The GMC was originally established in 1858 as the
statutory regulator of an independent profession in which each
practitioner was granted professional freedom but expected to
recognise that with professional freedom comes professional
responsibility. The GMC is the guardian of the standards which
are implicit in that compact.
Even its most ardent advocate is compelled to recognise that the
GMC has a mixed record in the discharge of that responsibility.”
The HSC commented again on this in their July 2011 report on the GMC.
“ The GMC clearly has a considerable amount of work to
undertake between now and the implementation of revalidation in
2012….. the GMC needs to accelerate its work with the medical
royal colleges to further refine the standards for revalidation in
specialist areas and to ensure that the process is meaningful to
clinicians and transparent to the public…...
Of the Officers who will have to make recommendations about
revalidating doctors, only a minority feel that the process will help
with the early identification of doctors with performance issues.
Early identification of problem doctors is a core task of the
102 Revalidation of Doctors http://www.publications.parliament.uk/pa/cm201011/cmselect/cmhealth/557/55703.htm
122
professional regulatory system, and the GMC needs to ensure that
its systems of appraisal and revalidation achieve this task.
The Committee notes the negative media reports about the time
taken to undertake revalidation and hopes that the GMC will
ensure that lessons are learned from the revalidation pilots”
The GMC’s record in respect of patient safety has been very lax.
12.2.4. Duty of Candour – disclosure to patients when things go wrong
Sir John Donaldson MR in Lee v South West Thames Regional Health
Authority [1985] 1 W.L.R. 845 at 850 and Naylor v Preston Area Health
Authority [1987] 1 W.L.R. 958 and 967 obiter dicta coined the
expression of the “Duty of Candour” in the sense of a doctor’s
professional obligation to tell the truth to his patients. But in Powell and
Boladz the Court of Appeal found that a doctor did not have any duty in
law to tell the truth to the parents of a dead child patient (“Robbie”). The
Powell case was refused permission to appeal to the House of Lords and
failed in an admissibility decision before the ECHR (on other grounds).
The Court103 nevertheless recognized the legal deficiency:
“Whilst it was arguable that doctors had a duty not to falsify
medical records under the common law (Sir Donaldson MR’s
“duty of candour”), before Powell v Boladz there was no binding
decision of the courts as to the existence of such a duty. As the law
stands now, however, doctors have no duty to give the parents of a
child who died as a result of their negligence a truthful account of
the circumstances of the death, nor even to refrain from
deliberately falsifying records.”
The decision of the Court of Appeal gave rise to considerable concern
resulting in July 1998,104 in guidance to the medical profession. There
was then first established an ethical duty to explain fully to patients (or
their parents) what has happened when something goes wrong:
“…..you should explain fully to the patient what has happened.”
It was for a long time before that generally felt it was best if the patient
did not know. Despite the guidance there has been little change
notwithstanding that most believe that:
103 45305/99
104BMA Handook “ Good Medical Practice” July 1998, para 17.
123
Increased openness and honesty following adverse events can
improve provider–patient relationships.”105
Years after it actually became a professional obligation and decades after
it should have been the honourable norm (well before the fear of medical
litigation became an excuse), what we actually find is that:
•A National Audit Office report in 2005 revealed that only 24% of
NHS trusts routinely informed patients of a patient safety incident
and, astonishingly, 6% admitted to never informing patients (A
Safer Place for Patients, National Audit Office, 2005).
•The Department of Health itself accepts that there is a ‘culture of
denial' in the NHS (Safety First, Department of Health, 2006).
 AvMA have been granted permission by the High Court for a
judicial review of a GMC decision not even to investigate
allegations of attempted ‘cover-up’, forgery and perverting the
course of justice by doctors [in this context].106
It may again be helpful to draw together two previous references in this
paper to openness and candour.
We saw in Para. 8.4 that the problem in Eire appears to have been similar
but they may have turned a corner in Irish hospitals scored consistently
high (>90%) on a number of openness issues as we saw in Para 4.9
above. So it is of course possible to become open.
We saw in Para 11.3 Recommendation 59 of the HSC 2009 Report on
Patient Safety that a key task of the Government was to ensure that the
NHS develops a culture of openness and "fair blame".
It comes as no surprise however that little has changed and that there is
stiff resistance within the medical profession to making this duty of
candour a legal requirement. There is however continuing pressure to do
so from a number of quarters including AvMA and RLT (“Robbie’s Law
Trust) who see this openness as conferring benefit in terms of patient care
and learning lessons. At the time of writing it remains to be seen whether
105 International Journal for Quality in Health Care 13.8.10; Disclosure of patient safety incidents: a comprehensive review ;
O'connor
106 http://www.avma.org.uk/pages/legal_duty_of_candour_-_robbies_law.html
124
a duty of candour will become (as we believe it should) a statutory
obligation for health professionals.
In the Eire Commission Report107 the principle is set out clearly with the
rationale.
“..every patient is entitled to open and honest communication
regarding his/her healthcare; every patient is entitled to be
informed regarding diagnosis and prognosis, treatment options
and chances of recovery if possible. If something happens to a
patient in the course of treatment and care which impacts or could
impact on the person’s health or quality of life, that patient should
be informed of this event, given an adequate explanation of the
event and reassured that measures have been taken to prevent such
an event occurring again in the future to him/ her or to anyone
else. Such disclosure is in keeping with the modern interpretation
of the doctor-patient relationship which is built on partnership,
open communication, dialogue and honesty. The Commission
acknowledges that challenges exist in relation to the fear of
litigation and the need to develop national standards for such
disclosure and supports for clinicians and patients in the aftermath
of an adverse event. However, it believes that these challenges are
not insurmountable.”
Compliance with the law should lead to honour and preferment within the
NHS rather than discredit and dismissal as too often happens now.
Candour is a major means by which risks from bad and dangerous
practices can be recognised and minimised if not eliminated.
Things are slowly changing. For instance 21 years after patients had to be
granted by Parliament the right to copies of their own medical records
under the Access to Health Records Act 1990, many GPs and most
hospitals do grant access to most records, but often reluctantly or with a
variety of unnecessary caveats.
There are still a significant number of GPs and their staff that have the
utmost difficulty with the concept of granting patients a copy of their
records even for other clinicians. “Why do you want them” is still heard
at the end stage of a long defensive argument.
Many hospitals still fail to disclose the all important records. One is
driven to conclude that the more critical, the more that turns on an
107 Ibid Reference 60; see Para. 8.4
125
individual record the more likely it is to be overlooked in the disclosure
process.
If that not uncommon experience (along with the other observations in
this sub paragraph) may be taken as a metaphor for the degree of
openness in the NHS, one is driven to conclude that the current level of
central exhortations and directives are not cutting the mustard. A step
change is needed.
12.2.5. The mandated VTE risk assessment data collection
As we saw in Para 7.3.2 data collection on provider compliance with
VTE risk assessment and communication of the data to DoH, was made
mandatory for all NHS providers from June 2010. This was because it
was recognised that 25,000 people were preventably dying annually from
VTE. There was a reasonable lead in time for the mandate and much
internal publicity about the DoH absolute prioritisation of eradicating this
killer condition. The data collection asks for three items of information108:
“1. Number of adult hospital admissions admitted in the month
[who were] risk assessed for VTE on admission to hospital
according to the DH/NICE National Tool
2. Total number of adult hospital admissions admitted in the month
3. Calculated from (1) and (2), the percentage of adult hospital
admissions, admitted within the month assessed for risk of VTE on
admission.”
Early indications were not good. Anecdotal evidence suggested that VTE
prevention was not being delivered effectively on the ground, due to
perceived difficulties in delivering the …goal. A conference was held in
April 2010 and guidelines published.
In March 2011, after the second publication of the data collection,
Andrew Gwynne MP was moved to ask the Secretary of State for Health
in written Parliamentary Questions
“1. What reasons were given by [13 named] Primary Care
Trusts for not complying with the requirements of his Department's
mandatory Venous Thromboembolism risk assessment data
108 DoH pdf VTE risk assessment data collection Q4 2010-11 Key Points
126
collection; and what steps he is taking to rectify this noncompliance?
2. What reasons were given by [4 NHS Hospital Trusts] for not
complying with the requirements of his Department’s mandatory
Venous Thromboembolism risk assessment data collection; and
what steps he is taking to rectify this non-compliance?”
The replies were not very illuminating. The third data collection (for the
first quarter of 2011) was published in June 2011. The tables are
published quarterly.
The full data tables can be found at:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publicati
onsStatistics/DH_127236
For the first quarter of 2011 about 5% of NHS acute trusts either failed to
supply the data at all, or submitted data merely based on a sample or audit
of patients and so were classed as a “nil return”. This echoes the second
question of Andrew Gwynne MP in respect of the previous quarter.
Of the majority of NHS acute trusts who did supply valid data, the
proportion of adult admissions risk assessed for VTE in all types of
providers of NHS funded acute care, rose from 47% in July 2010 to 83%
in March 2011. Put the other way, still 17% of inpatients are not being
risked assessed for VTE despite it being mandatory. Based on the
Inpatient episode statistics in Para 6.3 (Table 4) there were 17.3 million
inpatient episodes in that complete year, so 735,250 patients per annum
(or 2,000 inpatients a day) were still not risk assessed for VTE on
admission.
Between January and March 2011, the proportion of providers who
reported that at least 50% of adult admissions were risk assessed for VTE
increased from 88% to 91%. In March 2011, 115 of 179 providers (64%)
that reported, said that at least 90% of adult admissions were risk
assessed for VTE, compared to 18% in July 2010. So 36% of those who
reported, assessed between 50%-90%. Nearly 10% assessed nil or less
than 50%.
These figures taken with those in Para 12.2.6 below begin to show a
pattern that we pick up below in Para 12.2.9.
127
12.2.6. The Surgical Safety Checklist
We know from Paras 4.6.3and 11.5 below that these very simple effective
checklists –no more than an extension of common sense tools used by all
of us, save lives. One has to ask why did not surgeons or their physician
colleagues think of this decades ago? Why did it have to come from the
WHO?
“Surgical complications are a considerable cause of death and
disability around the world.109 They are devastating to patients,
costly to health care systems, and often preventable, though their
prevention typically requires a change in systems and individual
behavior.”110
Sir Liam Donaldson Chair of the NPSA was unequivocal.
“Hospitals not using a surgical safety checklist are endangering
patient safety.”111
No-one could have imagined quite how poor was going to be its reception
among the surgical community. The NPSA issued a Patient Safety alert in
February 2009 urging all trusts to adopt the Surgical Safety Checklist
praising its proven patient safety record.
At the first check by Patient Safety First (see para 9.6) 6 months later, the
results were not encouraging for such an efficient simple tool. Only 20%
of trusts had actually launched the programme in all theatres. Only 35%
of trusts were using the 3 phases of the checklist.
Patient Safety First published in June 2010 a report “Implementing The
SSC”. By then there had been some improvement in take up. There they
explained
“When asked, whether they had experienced any challenges when
implementing the Checklist, Trusts responded (more than eight out
of ten trusts mentioned one or more challenges):
lack of clinical engagement (77%)
109 Debas et al Disease control priorities in developing countries. 2nd ed. Disease Control Priorities Project. Washington, DC:
International Bank for Reconstruction and Development/World Bank, 2006:1245-60.
110 A Surgical Safety Checklist to Reduce Morbidity and Mortality…. Haynes et al; n engl j med 360;5 nejm.org january 29,
2009
111 NPSA website http://www.npsa.nhs.uk/corporate/news/surgical-safety-checklist-saves-lives/
128
Trusts noted that where clinical engagement was high,
implementation was likely to be better and vice versa.
“Some teams have embraced it, and so quite a few of the positives
have been achieved. However, some teams are pretty
unenthusiastic – mainly led by indifferent / hostile surgeons but
aided and abetted by anaesthetists and nursing staff to a greater
and lesser extent. These teams have, not surprisingly, experienced
a less positive outcome.”
“About six out of ten trusts are reporting positive changes as a
result of the Checklist (64%), but most said that they did not yet
have any quantifiable evidence of benefits.”
“Perceived advantages of implementing the Checklist include
improved teamwork, enhanced safety, capturing more near misses,
smoother and quicker procedures and better staff morale.”
Patient Safety First on 24th of June 2011 emailed an online survey about
the WHO Surgical Safety Checklist to 948 contacts who had registered to
receive emails from, and whose job titles were surgery, governance and
improvement related. Only 11% completed the online survey.
The purpose of the survey was to get an idea of what progress has been
made in implementation in hospitals in England since the previous report
in June 2010.
Summary of online survey results:
“• 73% reported that the Checklist has been fully implemented in
their Trust for every patient undergoing surgery
• 91% reported that the Checklist is being used for 80% or more of
patients undergoing surgery
• The main challenges to implementation were reported as:
improve communication (83%)
”
One sample response to the survey stands out:
“We have halved the number of surgical errors and have
demonstrated this statistically on SPC charts. We electronically
capture compliance on the theatre ORMIS system and we run at
>98% compliance.”
129
Nearly two and a half years after the checklist implementation, at least
one third of acute hospital trusts failed to respond at all. One can only
speculate what their response has been.
Of those that did respond 27% still lacked full compliance, a widespread
73% of Trusts (barely down from 77%) citing surgeons failure to engage
with the checklist.
At even the trust with the exemplary response 2% of patients (many
patients over a year) have to endure surgery without the checklist and one
in two of the surgical errors of those surgeons would have been avoided.
Those patients where the extra surgical errors lead to medical adverse
events have the right to be cross about the 2% failure.
12.2.7. Recognising the value of NHS complaints information
This is one important aspect of the vital human attribute of learning from
mistakes, that we already considered in general, and found the NHS
wanting.
“Effective handling of complaints is an essential part of
governance. Most importantly, they provide a person affected by
poor care, or by other deficiencies in service, the opportunity to
seek recognition and redress. Complaints provide vital information
to the Trust about its performance, and are a valuable source of
learning about deficiencies that need to be remedied.”112
We recall from Para 11.3 Conclusion 9 of the HSC the scepticism of the
committee that much progress would be made under this heading.
A working draft agreement , has been produced setting out the position of
key stakeholder organisations on the need for meaningful, comparable
complaints information which can inform the development of healthcare,
strengthen the quality of services provided and support enduring
improvement for patients and the public. The document is a draft which
was made available to the National PALS Network (NPN) in November
2010.
112 The Francis Inquiry Para 73. See Para 9.6 and Reference 76 for a link to the Inquiry Report.
130
The document was ratified in March 2011. No-one has implemented the
need. We share the scepticism of the HSC.
The NHS seems incapable of implementing this sensible agreed plan.
As to the complaints system itself we could not hope to put it better than
the HSC in their Report on this subject113
Patients have the expectation of, and are frequently given, world
class care and treatment by the NHS. Sometimes experience falls
well below the high standards expected, and when this happens
patients should have access to a responsive and effective
complaints system. However, the NHS complaints system
sometimes compounds and exacerbates the negative experiences of
patients. In such situations, patients have little choice but to give
up or turn to the legal system. It is worth noting that the motivation
of complainants is often not to seek compensation for failures of
care but rather to have their concerns listened to and acted upon in
order to reduce the likelihood of similar failings happening again.
12.2.8 Putting Patient Safety at the top of meeting agenda
We have already looked at Mid-Staffs in Para 11.2 but we venture a
further reference to this important safety report as it makes an important
point about how this theme of putting patient safety at the top of the
agenda has been said before and not acted upon.
“Chapter 2 Safety
43. In the covering letter to his report on the C. difficile outbreak
at Stoke Mandeville in 2006, Professor Sir Ian Kennedy stated:
“we demonstrate again the need to place the safety of
patients at the forefront of the agenda of healthcare. Safety
cannot ever be allowed to play second fiddle to other
objectives that may emerge from time to time. It is the first
objective.”
44. By “again”, Sir Ian was referring to the fact that he had
occasion to enunciate the same message in his inquiry into
children’s deaths in Bristol”.
Sir Ian concluded in 2001 in his Inquiry at Bristol that Cardiac surgery
services were “simply not up to the task”114, because of shortages of key
113 Ibid footnote 83
114 P 67 “Safety
131
surgeons and nurses, and a lack of leadership, accountability, and
teamwork. Again human factors were largely at play.
In his final report “High quality care for all: NHS Next Stage Review
final report” dated 30th June 2008 Lord Darzi stressed the fundamental
importance of putting patient safety at the top of the agenda.
“The first dimension of quality must be that we do no harm to
patients…….
Continuously improving patient safety should be at the top of the
healthcare agenda for the 21st century.
The injunction to ‘do no harm’ is one of the defining principles of
the clinical professions, and as my Interim Report made clear,
safety must be paramount for the NHS. Public trust in the NHS is
conditional on our ability to keep patients safe when they are in
our care.
Safety is the responsibility of all staff, clinical and non-clinical.”
Interestingly the Patient Safety First Campaign took a look at this
injunction (in the literal sense of trust boards’ agenda) as it was one of its
key messages.
In its concluding survey “Patient Safety First - the campaign review”
published on 22/6/11, it found:
“by the end of the campaign, 61% of acute trusts had patient safety
and quality as their first agenda item; this was a significant
increase from a similar Board paper analysis conducted in 2009
where the proportion was just 18%.”
We find that despite Sir Ian Kennedy’s repeated urging, and
notwithstanding Lord Darzi’s clarion call three years earlier and after
two years of exhortation and coaxing by the Patient Safety First
Campaign and with the din of Mid-Staffs still ringing in their ears, nearly
40% of trusts could not even be bothered to comply with this simple
obvious step.
12.2.9 Summing up
There are surely clinicians and trusts out there whose patient safety
record is excellent, perhaps faultless. Although looking at Dr Foster’s
132
Trust Safety Ratings (para 4.7) as to trusts they appear to be in a minority
or small minority respectively.
“Each time that a major patient safety scandal has come to light,
the Government have assured us that it is a unique case and that
no other NHS bodies are in the same situation-and then, normally,
within about three to six months, we get an example that seems to
disprove that.”115
This well rehearsed public relations strategy has worn thin. Astonishingly
it is still reported without obvious disbelief. We recognise it especially as
used by the Trust spokesperson after most well publicised medical
adverse events. The slant is slightly different though.
It usually runs something like “we have learnt from this long ago event,
medical science has moved on and patients can be re-assured that this sort
of thing will never happen again.” Not infrequently it relates to CP
caused by yet another failure to read a CTG chart. We are expected to
believe this.
The problem with large healthcare organisations is that if only a small
minority are not safe that still creates a lot of death and injury. Other
industries have grasped this message as others including Vincent have
pointed out.
If only 0.1% of flights (1 in 1,000) crashed, that would still kill a lot of
people. Taking up the WHO theme in PSF 9 (at Para 4.5), the odds of
being killed on a single airline flight with one of the bottom 25 airlines,
with the worst accident rates, are approximately 0.0001% falling to
0.00001 with the safer 25 airlines.116
This compares with the risk of death, of about 0.25% due to a medical
adverse event on being admitted to an NHS hospital.
Sensible, patient safety, life saving, ideas and strategies are being
devised. Some have been implemented sooner or later. Others have been
fought and delayed as long as feasibly possible, often by a vocal minority.
115 Rt Hon Kevin Barron MP; Chair, Health Select Committee; Adjournment Debate on Patient Safety Report House of
Commons 18/3/10
116 http://planecrashinfo.com/cause.htm
133
These strategies are demonstrated as clearly feasible by the majority but a
small percentage (affecting nearly ¾ of a million people in the case of
VTE screening) will not comply.
We are at the cross roads. Is all the government, DoH and NHS rhetoric
about patient safety, just rhetoric? As the Royal College of
Ophthalmologists (Appendix Para A2.1) put it to the HSC: we now need
the resources and clinical leadership to put these thoughts into action. The
patient safety mindset and memory is present, it now needs limbs.
“Otherwise it is all talk and no action.”
If the patient really does come first it is axiomatic, in the case of a
conflict between patient safety and the interests of any surgeon or trust,
the latter come second. They have to toe the line. There cannot be any
debate.
To make a balanced judgement though we need to ask whether we should
accept that medicine is partly an art and that trusts (especially foundation
trusts) and clinicians, in the face of compelling evidence to the contrary
should have the absolute right to go their own way?
If so then the NHS must be honest and open and flag up these doctors for
the patient so he or she can make an informed choice.
In our view the non compliant minority who:
o are treating patients for days in hospital absent VTE screening
o or operating without the Surgical Safety Checklist,
o the trust staff who will not ensure their medics speak adequate
English
o or place Patient Safety at the top of the agenda,
o or who can not implement learning from mistakes and an open
honest workplace dedicated to the patient’s safety
must be asked to choose between compliance for patient safety or another
career in which they may flourish.
After so much inertia, now the only way, of making things safer is to
impose rigid, strict and closely observed regulation.
The health sector and its regulators have lost any right they had to the
monopoly of control of the problem. Physicians (in the broad sense) have
failed for too long and too often to cure themselves. The DoH and
134
regulators both, have a shameful history of failure to make significant
advances in fixing, this grave crisis. This failure has been well described
by The HSC.
12.3 Is there a duty to make a greatly enhanced effort?
This question could be put thus - shall we just carry on as we are, as in
the last 10-20 years making an effort but lacking the power to improve
patient safety significantly, with a significant lack of clinical and trust
engagement, and with regulatory confusion and failure? The NHS
complaints statistics show an increase of 13.4% in complaints between
2008-09 and 2009-10 to a record high, hardly evidence that the current
effort is adequate. For acute inpatient services the increase was nearer
6.5%, but the relative 2010-11 figures show only a very slight decrease.
The difference needed to win is great. Only a total effort, an all out war
on medical adverse events will suffice. Huge resources, a complete
change of attitude and total focus is required.
We remember from the HSC’s Conclusion 21 that a
“culture persists in which various types of harm to patients are
seen as inevitable….”117
That smug and callous disregard for human life is not a respectable,
politically acceptable, humane or just approach.
There simply has not been the political will to take the necessary action to
bring the death toll to an end. Strangely the people have slept through this
scourge.
Somehow there is a blind spot about fatalities from medical adverse
events. Like society’s long held approach to child abuse, we may feel
medical adverse events are too awful to believe. They seem to challenge
our deeply held trust in the medical profession.
We see medical adverse events when we are looking for them, when our
attention is specifically drawn to them, but not often otherwise.
For example as we saw in Para 7.4.1 NHS London’s Health Observatory
(LHO) published in 2002 a Report “Too high a price. Injuries and
accidents in London” and produced a factsheet in February 2011 along
the same lines.
117 Health Select Committee’s Report on Patient Safety Para 11.3 above
135
The LHO produces information, data and intelligence on the health and
health care of the 7.8 million people who live in London for health
practitioners and policy-makers to assist with commissioning and policy
decisions.
LHO on their website state the 2002 Report:
“is the first report of its kind to give a comprehensive view of
injury and accidents in London.”
The Report goes on to say that every year in London there are around
2000 deaths from injuries or accidents and nearly 70,000 admissions to
hospital. It goes on to list the causes as: Self Harm, Assaults,
Undetermined Injury, Fall (accidental and intentional), Fall from a height
(accidental and intentional), Road traffic accident, , Plane/Helicopter
accident, Train/tube incident, Fire incident (accidental and intentional)
and Assault, Self-harm (accidental and intentional), accidental poisoning,
Other accident, and finally Medical misadventure and adverse effects.
This “comprehensive” list, numbers the latter category as 40 annual
deaths in London. It chose this figure rather than the conventionally
accepted DoH figure (of 72,000 deaths per annum, repeated in most
pertinent NHS publications).
The conventional figure, pro rata for London, would be 9,300118 annual
accidental deaths through medical adverse events to hospital inpatients
caused by the website host: the NHS.
The reason NHS London chose this wildly erroneous figure is in our
view, not some shocking conspiracy to deceive Londoners. Healthcare
workers strive to be their best, to cure patients in a great model of social
medicine.
As succinctly observed by the Clinical Human Factors Group, (Appendix
A2.3 - 5.2.1) clinicians have been trained to believe that error should not
occur rather than to recognize that all humans make mistakes and need
skills to manage and avoid them. In the NHS, error is still viewed as
weakness and poor performance. It is illustrated by major under-reporting
of adverse events.
118 9300 deaths per annum is calculated by applying the percentage of London’s population (7.8M) of the national population of
60M (13%) to the national benchmark data figure of 72,000 medical adverse event deaths
136
The NHS and most of society are in a state of self denial about the scale
of the problem.
We know that medical adverse events have catastrophically affected a
significant minority of those who are admitted to hospital. Yet there has
been no imperative to prevent the loss of life.
Instead, issues like waiting lists have risen high up the political agenda.
Part of what has happened though (in addition to brave effort by a tiny
minority) is that there has been in the past a lot of opprobrium heaped by
society as a whole on those associated with the “exorbitant” sums
claimed and “won” against the NHSLA. In the same vein:
“Clinical negligence litigation, as a barrier to openness, should be
abolished.”119
This notion gained some credence at the time but was rightly eventually
binned.
Many of the medical experts who give evidence for victims of medical
adverse events speak to us about the development of clinical negligence
litigation.
They are open enough to say that the discipline has drawn to the attention
of those in the medical profession who were willing to hear it, an
important message about the lack of patient safety.
The HSC 2011 report on Complaints and Litigation120 examined the
arrangements under which the NHS handles litigation by patients.
The committee concluded
“that the existing clinical negligence framework (based on
qualifying liability in tort) offers patients the best opportunity
possible to establish the facts of their case, apportion responsibility
for errors, and secure appropriate compensation.”
and regarding the Government proposals which will reduce access to
legal aid for most clinical negligence cases:
119 Bristol Royal Infirmary Inquiry; final report, Summary
120 Ibid footnote 83
137
“The committee warns ministers that the public will judge these
proposals by how they alter access to justice. The Government
must take care to gauge its proposals against this yardstick.”
The idea that the lack of openness (or candour) was some new thing that
came along with the advent of clinical negligence litigation in the UK in
the late 1980s was absurd. As noted above (para 12.2.4) the professional
duty of candour (for doctors) was only introduced in 1998.
For the rest of society it had ever been present. Doctors have been
burying their mistakes for a very long time. Frank Lloyd Wright, the
American writer to whom this remark is attributed died in 1959.
We have not only “shot the messenger” but ignored the message. More
than a third of a million persons have preventably perished and millions
have been significantly and avoidably injured over the last decade alone.
Has the government been safe from a public outcry because there has not
yet been a sign of much public awareness? Does the absence of societal
outrage justify a knowing government’s failure to act?
The government, in a modern society, is the holder of a clear duty in
relation to the health of its citizens, not merely as to the provision of a
health service, but a safe one.
As we noted from Professor Evans reference in his Railway Risks Paper
at Para 6.2 earlier, the burden and extent of that duty to keep people
(here patients) safe is heavy. A safety duty holder must implement safety
measures up to the point at which the costs are not merely equal to the
value of the risks, but ‘grossly disproportionate’ to them. This is how
Lord Justice Asquith put it in The Court of Appeal121:
“The onus was on the defendants to establish that it was not
reasonably practicable in this case for them to have prevented a
breach of s. 49. The construction placed by Lord Atkin on the
words " reasonably practicable” in Coltness Iron Co. v. Sharp (1)
seems to me, with respect, right. " Reasonably practicable” is a
narrower term than " physically possible " and seems to me to
imply that a computation must be made by the owner, in which the
quantum of risk is placed on one scale and the sacrifice involved
in the measures necessary for averting the risk (whether in money,
time or trouble) is placed in the other ; and that if it be shown that
121 Edwards v National Coal Board; 1 KB 704 21 March 1949; Tucker, Asquith, Singleton L.JJ.
138
there is a gross disproportion between them—the risk being
insignificant in relation to the sacrifice—the defendants discharge
the onus on them.”
That case remains good law122.
So let us do the computation: place on the scales –
the annual quantum of risk to society as a whole on one scale and the
sacrifice - the measures necessary for averting the risk (whether in
money, time or trouble), here measured in investment in patient safety, on
the other.
There is a gross disproportion between them but the disproportion is
inverted. The sacrifice is insignificant in relation to the risk:
£68-81 Bn of risk against perhaps £100M of sacrifice.
Even if the duty were limited to the value of the risk: governments have
fallen tragically short of the target in terms of investment of resources in
patient safety.
It may be instructive to see what we have been prepared to spend to
enhance life or even to prevent the further loss of life:
o £9.24 Bn when 2996 people (including 66 UK citizens) were
murdered by terrorists on 9/11
o £18 Bn on ID cards
o £11.4 Bn on NHS IT systems (failed)
o £4.6 Bn on the Digital switchover
o £20-76 Bn on Trident
Given the cost of avoidable medical adverse events we can not continue
to remain in denial and ignore the reasonable demands of all who seek to
address the problem.
There is a clear and imperative duty on our government to act to protect
its people.
12.4 Is there is a reasonable prospect of success?
12.4.1 Progress
122 Baker v Quantum Clothing Group Limited and others [2011] UKSC 17 para 184
139
Even with the level of investment to date some progress has been made in
limited areas to some degree. The Surgical Safety Checklist has already
saved lives.
12.4.2 Government power to influence behaviour
Even in a field with little government control over the behaviour of
offenders, deaths from drink driving have fallen by 85% from 1,640 per
annum in 1979 to 250 in 2010.
“The reasons for the decline include the introduction of a series of
government measures that were designed to improve the
enforcement of the laws and to revise the penalties on conviction.
These include the introduction of evidentiary breath testing
devices, resulting in increased police enforcement levels;
clarification of anomalies in the drink/driving laws; the
introduction of the "High Risk Offender" scheme, which requires
offenders to pass a medical test before driving licenses are
recovered; and increased penalties, including imprisonment, for
drinking drivers who caused death by careless driving.”123
When government has had a reasonable measure of regulatory control
over outcome, dramatic falls in fatalities have become a matter of record.
o deaths in the air industry: Fatal Air Accidents in the UK in pistonengined aircraft per million flying hours fell from 100 in 1921 to 8
in 1960.124
o deaths in industry: the rate of fatal injury (per 100,000 employees)
in the UK fell from 2.9 in 1974 to 0.5 in 2009/10.125
o road deaths generally peaked in the 1960s at about 8,000 and have
since fallen to 1857 despite exponential growth in traffic volume
o in medicine - AIDS:
“the introduction of combination antiretroviral treatment in
the mid-1990s has resulted in a steep decline in the number
of AIDS cases and deaths reported each year. In 1997
around 750 people living with HIV died, compared to 1,723
two years earlier. Since 1998 the number of deaths among
123 The Worldwide Decline in Drinking and Driving; Barry M. Sweedler; National Transportation Safety Board, 490 L'Enfant
Plaza, S.W., Washington, DC 20594, USA accessed at http://www.druglibrary.org/Schaffer/Misc/driving/s18p1.htm
124 RW Howard The Aeronautical Journal 11/00
125 HSE website accessed 1/6/11
140
people living with HIV has remained more or less constant,
averaging around 400 to 500 per year”.126
o when deaths were carefully and fully investigated by CEMACH.
There has been a dramatic reduction in the maternal death rate in
the UK since the 1950s when the Confidential Enquiry was
introduced. The rate was around 70 per 100,000 live births in 1952
to around 11 per 100,000 live births in 1982.127
12.4.3 Prospects of success
The answer to the question of viability is in our view is a resounding yes.
It goes without saying that much of it will not be easy. In the field of
regulation, there is ample evidence of the ability of HM Government to
dramatically reduce fatality and serious injury. We can and must regulate
the health sector into safety. This only happens when great leadership,
adequate investment of resources and the best minds are applied.
12.5 Recommendations
o A very significant boost, a quantum leap is given to the investment
of resources in patient safety generally and specifically into the
application of human factors.
o The MAIA as described in Paragraph 13 is set up
o The Recommendations in Paragraphs 1-59 of The HSC Patient
Safety Report Conclusions and Recommendations are effected
o An equivalent to the US National Practitioner Data Bank is set up
in the UK
o A simplification and enhancement of health sector governance
structures is introduced with an emphasis on patient safety.
If this level of death and injury were being suffered in any other
environment than our much loved NHS, society and government would
have not have stood by in hapless ignorance and done nothing.
The roof would have been raised. Decisive action would have been taken.
That time is overdue.
126 http://www.avert.org/uk-statistics.htm
127 Saving mothers’ lives: the contribution of the Confidential Enquiries into Maternal Deaths to improving maternal health in
the UK Gwyneth Lewis; http://www.radcliffe-oxford.com/Books/samplechapter/0495/Dob_chapter%201-64526e80rdz.pdf
141
13. THE PROPOSAL - A MEDICAL ACCIDENTS INVESTIGATION
AUTHORITY
13.1 The key to improving safety is the proper, effective and objective
investigation of accidents which cause injury and death but no such
system exists in the NHS.
13.2 Greatly to the credit of the Association of Surgeons of Great Britain
and Ireland and the Royal Colleges of Surgeons, a confidential reporting
system in surgery (CORESS) mirrored on the effective CHIRP
(Confidential Reporting Programme for Aviation and Maritime) has been
established. These systems enable lessons to be learned from incidents
and near misses, which might not otherwise come to light but reliance
cannot be placed only upon encouraging openness about serious medical
untoward incidents or accidents. A statutory, demonstrably independent,
accident investigation authority is required.
13.3 In 1915, through an Act of Parliament, this country instituted an Air
Accidents Investigation Branch (AAIB) to provide independent
investigations into military flying accidents; the scope of AAIB
investigations was later extended to the commercial and leisure aviation
sectors. The Marine Accident Investigation Branch (MAIB) was formed
in 1989 following the Public Inquiry into the Herald of Free Enterprise.
Again one of the principal objectives was to provide an independent
accident investigation agency. The AAIB and the MAIB have been
instrumental in transforming the standards of safety in their respective
operating environments, are now widely regarded as benchmark
organisations in safety investigations and have been widely copied by
other countries.
13.4 In our view there should be a Medical Accidents Investigation
Authority (MAIA), set up to operate along similar lines in the United
Kingdom128.This Authority would be completely independent of the NHS,
although ultimately responsible to the Secretary of State and it should
have full powers to investigate the causal and circumstantial factors
associated with all fatal and serious medical incidents, publish reports and
make recommendations. The Authority would not apportion blame or
provide evidence for criminal investigation and/or disciplinary action. It
would, however, take precedence over all other investigations, including
128 The proposal of an MAIA was first published in a paper by Dr Michael Powers QC, Mr Denis Wilkins FRCS Past President
of the Association of Surgeons of Great Britain and Ireland and Mr Peter Tait CEO of CHIRP
142
those of the police, the coroner, the CPS and civil and regulatory
authorities.
13.5 We neither can nor would wish to draft the powers proposed for the
MAIA in this paper but in outline these should include:
Free access to all buildings and sites where any relevant
documentary or other evidence may be held;
The power to requisition and inspect all documentation and other
evidence including that otherwise protected by legal or
professional privilege or covered by the Data Protection Act;
nothing should be excluded from the MAIA;
Full power to embargo and test equipment;
The power to require witnesses to attend for interview without
legal representation and to attest to the truthfulness of statements of
evidence;
The power to order a witness not to have contact with other
potential witnesses;
The power to prohibit any person having access to any building
where the matter under investigation occurred;
The power to close or suspend the operation of any department or
organisation within which the medical accident occurred until such
time as its investigation is complete.
13.6 Given the enormous number of patients injured or whose deaths are
materially contributed to by unacceptable levels of care, the MAIA could
not investigate every case. Nevertheless it should have these powers to
investigate any case referred to it.
13.7 Such powers may be considered draconian. They are – but no more
so than those granted to the other statutory accident investigation boards
(air, marine and rail) after Herald of Free Enterprise (in 1987) only a
quarter of one percent of the annual deaths in medicine. They are
necessary. No person or Trust should be under any illusion about the
seriousness of matters affecting patient safety. There should be no corner
to hide, no reliance on professional obligations or “data protection”.
143
13.8 The safeguards are (i) that the sole purpose of the MAIA is to
investigate the cause of a medical accident – not to apportion blame and
(ii) the sole objective is patient safety and the exercise of the MAIA’s
powers is exclusively to ascertain cause and to take all the measures
considered appropriate to prevent a recurrence until that cause is
ascertained.
13.9 Individuals would be protected by complete privilege in their
statements to investigators. Under no circumstances could any court or
authority have sight of such evidence without the express consent of the
witness. Accordingly there could never be any risk of “selfincrimination”, admission of civil liability or susceptibility to
professional regulatory censure arising from any oral or written evidence
given by a witness to the MAIA inspectors. Whilst the MAIA report
might be accessible, its conclusions would certainly not be binding on
any court.
13.10 Neither the NPSA nor any other NHS agency or independent
agency has such powers. Effective, independent investigation provides
the key to ensuring that lessons from medical accidents really are learned.
All involved in patient safety should welcome a MAIA: it is essential to
ensure high standards and improve morale in the NHS.
APPENDIX 1
EXECUTIVE SUMMARY TO THE 2002 PAPER “NHS HOSPITAL
ACCIDENTS AND OTHER ACCIDENTS COMPARED”
According to the NHS own figures there are nearly 1 million NHS
hospital accidents (“medical adverse events”) every year in English NHS
hospitals. These result in about 73,000 deaths each year and 211,000
people moderately or severely injured.
These figures mean an adverse incident rate of 11.7% (about 1 in 10) of
all patients admitted to hospital. The Department of Health (DOH)
claims this rate is similar to other European countries. It compares very
poorly to an equivalent rate of 3.7% in the USA but well to 16.6% in
Australia.
To put the absolute numbers in perspective; in terms of deaths each year,
medical adverse events cause more deaths to patients in English hospitals
144
than enemy forces caused deaths to UK citizens each year in World War
II.
Currently the DOH appears very concerned about cutting the cost of the
resulting compensation claims: about £370 Million pa. These have arisen
for a variety of reasons, however there is evidence for them levelling out.
Rather than being "unacceptably high" they are in fact low, relative to
claims arising from road accidents, and only 1/5th of the cost of
immediate hospital treatment for the victims of all medical adverse
events.
Too much emphasis is placed on this compensation figure and too little
on the cost to society as a whole. Using a well tried government formula
"the Value of Prevention" (used by the Department of Transport (DOT)
for road accidents) we find that economic cost of medical adverse events
is an additional £10 Billion (£10,000M) pa. In terms of both lost output
and the cost of resulting additional hospital treatment of the victims; on
the same basis the "human cost" is £30Bn (£30,000M).
Although these figures are shocking it must be remembered that the vast
majority of NHS staff are highly skilled, dedicated and work very hard
for too many hours. Most errors are thought to be systemic, due to a
weak system. Like accidents at work, they can be largely prevented by
adequate investment in safety. The safety outcome is obviously related to
the adequacy of investment in safety.
The new National Patient Safety Agency (NPSA) is therefore very
welcome.
What is of great concern is the adequacy of its budget and thus the extent
of the resulting safety outcomes. The NPSA is only one of several
agencies and initiatives but it is the lead body involved. Comparisons can
be made between government sponsored industries’ investment in safety
systems per prospective life to be saved, i.e. how much is spent to save a
life.
The DOT has decided to spend £5M per life prospectively saved on the
cheaper Train Warning Protection System to avoid tragedies like
Paddington. Unfortunately, the budget of the NPSA equates to a mere
£250 per prospective life to be saved; but a tiny fraction (1/20,000th) of
the railway spend.
145
Now the government is beginning to grasp the significance of the
problem the people may not tolerate for too much longer, further massive
under investment in hospital safety.
APPENDIX 2
EXTRACTS FROM THE HOUSE OF COMMONS HEALTH
COMMITTEE REPORT ON PATIENT SAFETY (PUBLISHED JUNE
2009)
A2.1 From a Memorandum by the Royal College of Ophthalmologists:
“Since the publication of an Organisation with a Memory
(Department of Health, 2000) the NHS has made better efforts to
improve and or ensure patient safety. However, for many years
before that report and most importantly ever since then, NHS
organisations have perpetuated a performance management and
target culture, rather than a safety culture….
The College has concerns that not enough has been done to retain
the ideas in an Organisation with a Memory and that time and
effort is still needed to ensure that new NHS organisations
understand and can foster a culture focused on patient safety.”129
“recent policy directions refreshing patient safety at conceptual
levels are welcomed. What are now needed are the resources and
clinical leadership to put these thoughts into action. The patient
safety mindset and memory is present, it now needs limbs.
Otherwise it is all talk and no action.
………It is estimated that approximately 10% of healthcare
episodes and interventions are compromised in some way by
clinical errors, 50% of which are preventable. It is thus argued
that 10% of resources should be allocated to patient safety or
quality matters130. To date this has not occurred. Payment is by
129 Para 2.5 of the Memorandum
130 The source of this argument that only 10% of resources should be allocated is unknown. See para 12.3 of this paper and the
extract from Edwards v National Coal Board footnote 121
146
activity regardless of quality. Investment in clinical leadership of
patient safety and quality has been lacking and may be a
worthwhile development which might re-energise clinical
engagement in these areas.131”
“Reports from NHS agencies and others following patient safety
incidents should be publicised (but in an anonymous format) and
discussed in a mature professional manner by healthcare
organisations and relevant clinicians with an aim to seek local and
wider implementation of lessons learned. Evidence of such
endeavours might form a part of the appraisal of consultants and
the accreditation of clinical services.
Investment will be needed for this vision to mature and for
evidence of its implementation to be robust.132
A2.2 From a Memorandum by the Health Foundation
“1.1 NHS care and treatment is replete with avoidable error. The
bulk of this is caused by system failure resulting in chronically
unreliable care delivery.
1.2 The managerial and clinical leaders of all acute hospitals in
England should make patient safety their top priority,
implementing proven changes in clinical practice to reduce harm;
banishing the blame culture; and changing the way they identify
risks and measure performance.
1.3 Ministers and NHS top management can aid this by ensuring
a coordinated use of managerial, commissioning and regulatory
levers. They should lead by example, putting patient safety, visibly
and practically, at the very top of their agendas. Responsibility for
patient safety at the Department of Health should be clarified and
backed with sufficiently senior and experienced technical expertise.
In the context of High Quality Care for All: NHS Next Stage
Review Final Report, they should act to build a cadre of expert
clinical leaders in patient safety[153].
1.4 Other industries have seriously addressed safety and the
same can be done in the NHS. Healthcare is highly complex and
there are no quick fixes. A holistic approach is necessary. Senior
leadership, clinical engagement and a committed workforce are all
131 Para 2.8.1 National Policy
132 Para2.9 What the NHS should do next
147
vital. Time must be invested in embedding a long-term safety
culture.
1.5 The Health Foundation's work over four years with 24
hospitals across the UK has many lessons for the rest of the NHS.”
“3.2 In 2000 the Department of Health's An Organisation with a
Memory143 painted a stark picture of an NHS without systematic
ways of identifying error, learning from its causation and reducing
risk for future patients”.
A2.3 From a memorandum by The Clinical Human Factors Group
“1.1 Since 2007 the Clinical Human Factors Group (CHFG) has
brought together leading experts in human factors (HF), both
academics and frontline clinicians, to identify and promote best
practice. It is an independent charitable trust (Registered no
1123424). Its members believe that the lack of HF training in
medicine means that patient care is more hazardous than it could
and should be.”
“2.1 Many safety-critical industries have reduced accidents and
harm by knowledge of error theory and HF principles. The
inevitability of human error is accepted. Importantly it is not
viewed as poor performance, and so concealed, but openly
reported to drive improvement. Systems design and the appropriate
training of staff assure safety.
2.2 Training in HF skills such as teamwork and communication is
virtually absent in healthcare. It should be mandated by regulation,
taught and examined. The appropriate professional bodies should
be active partners in examining and assessing competencies in
non-technical skills (NTS) and HF for both trainees and qualified
staff.
2.3 Those who work together should train together. Research has
shown that teamwork training may reduce technical errors by 30 50%.
2.4 There is a clear correlation between HF skills and the
frequency of error in operations. Minor errors are frequently
tolerated but they are significant as they accumulate to cause
major hazards. Minor errors must be recognized and reduced by
HF training.
148
2.5 Clinical staff must be involved in both defining the problem and
suggesting the solutions. Sustainable improvements have been
demonstrated by this approach. The prevailing top-down culture of
clinical governance does not work.
2.6 Blame invites denial among professionals doing their best in
poor systems. Central policy should ensure a fair blame culture so
that the reporting of error is encouraged. Inadvertent error that is
openly reported should attract immunity from sanction.
2.7 We are concerned that the current model whereby internal
investigations are carried out by healthcare staff after a short
training. This is not a robust approach to embedding incident
investigation and results in a lack of independence. The current
approach should be reviewed by an expert from another industry.”
“5.2.1……clinicians have been trained to believe that error should
not occur rather than to recognize that all humans make mistakes
and need skills to manage and avoid them.
In the NHS error is still viewed as weakness and poor performance
(Bromiley, 2008). It is illustrated by major under-reporting of
adverse events (NAO 2005). Such a culture fosters denial and is
the hallmark of hierarchy in the workplace. No major safetycritical industry would accept this at a strategic or operational
level.
The Civil Aviation Authority states “human error is inevitable what
is important is to ensure that (this) does not result in adverse
events such as accidents”; “specific training should concentrate
particularly on error detection”. (CAA CAP737 2006).
5.2.2 Studies of surgical adverse events reveal a large number of
causal factors embedded within a highly complex system (Vincent,
Moorthy, Sarker, Chang, & Darzi, 2004).
There is an interplay of organisational, cultural and team factors
that constantly threaten safety. These factors, often referred to as
the “system” are critical to performance, but all systems are
operated by people.
Improvement therefore depends on educating and empowering
them. With help they will know how to make their own work safer.
The nuclear and aviation industry act as clear and successful
examples. The same approach is required in surgery
(Giddings and Williamson 2007).”
149
“6.1 A significant body of research on teamwork and
communication in operating theatres, confirms that
communication breakdown is frequent and hazardous (Christian et
al 2006). Problems shared with the aviation industry have been
highlighted, particularly difficulties with cultural hierarchy, which
inhibits team members from sharing their situational awareness
clearly in critical situations.
6.2 Studies in paediatric cardiac surgery at Great Ormond Street
showed a clear correlation between the quality of teamwork and
the frequency of technical and procedural errors in operations
(Catchpole et al. 2007) and this has been confirmed by the QRSTU
group in Oxford (Catchpole, Mishra et al. 2008). Not surprisingly,
operations where there are a large number of minor technical
errors are more likely to result in a serious major problem.
6.3 Despite the differences between surgery and civil aviation, in
HF issues, there are striking similarities. In Oxford, a detailed
before and after training study has shown that staff exposed to
teamwork training based on aviation Crew Resource Management
(CRM) made 30±50% less technical errors after training
(McCulloch et al. 2008). The effect was variable, but it is likely
that changing team culture in the operating theatre will reduce
harm to patients.”
“7.1…….. every minute there are uncontrolled events in healthcare
which would not be permitted in any other high risk industry. We
need to ask why? It is partly because healthcare is uniquely
complex but it is also because what could have been done to
improve the training of staff and the systems in which they work
has not yet been done. This is despite clear identification of the
need for at least eight years, since the publication of “An
Organization with a Memory” and the NHS Plan, to which there
was a clear professional response identifying “the central
importance of improved investment in surgical education and
training” (FSSA Response 2000).”
“7.4 Effective education must be supported by regulation, an
appropriate curriculum, time, and money. It also requires a
workforce of trainers who have been selected and trained to teach.
It must also be quality assured, assessed and examined.
In the generic and critically important field of HF none of this has
taken place.
150
7.5 The heavy reliance of the NHS on the service contribution of
trainees has led to a ratio of excess trainees to fewer trainers,
which is the reverse of that found in every other developed country.
There, trained doctors deliver the majority of care.”
“8.5 The NHS has benefited from huge recent investment but little
of that has been applied to the overwhelming and generic need to
change the systems in the workplace and the culture of
professionals.
8.6 If the safety of patients is to be improved, a sustained and overt
commitment to training in human factors and systems improvement
is unavoidable. This is a moral imperative not a strategic option.”
A2.4 From a Memorandum by Guy Hirst and Trevor Dale that echoed the
last observations
“We have been an integral part of several research programs
investigating human error in operating theatres for over 6 years
and have witnessed at first hand many traits within healthcare
professionals that would not be tolerated in aviation and other
high-reliability organisations.
There is an unhealthy tendency to focus on blame rather than
learning and a significant reluctance to change particularly
amongst those with enhanced status in the professions.”
“1. In the course of our participation in research work over the
last 6 years at several Teaching Hospitals and DGHs we have
observed the multi-disciplinary operating theatre teams in various
surgical specialties.
During this work we have observed numerous examples of less
than effective team working in the operating theatre. Such
examples have the potential to cause patient harm.
2. We have a combined experience of 70 years in Commercial
Aviation. We recently retired as senior training captains for British
Airways. Since 1990 we have both been leading members of the
small team that pioneered ªhuman factorsº training in aviation. In
the last 18 years we have learnt a great deal about how to embed
this essential training into the culture of an industry. Despite the
many overtures by those responsible for Healthcare in the United
Kingdom the understanding of the importance of Human Factors
151
is negligible.”
“6. We are two of the representatives mentioned by the CMO [in
State of Public Health for 2007133]. As mentioned earlier we refer
to the skills alluded to by the CMO, Human Factors skills. Human
Factors are those skills, not directly technical, that describe how
members of a team function effectively and safely. Human error
cannot be eliminated; it is an essential facet of the human
condition. However efforts can be made to mitigate, catch and
minimise errors and threats by attempting to provide people with
appropriate skills to cope with the risks and demands of their work.
These skills are the cognitive and social skills that complement
workers' technical skills. Whilst many healthcare professionals
intuitively demonstrate these skills many others do not. In aviation
and other safety critical industries it has long been recognized that
these skills are trainable.
Over the last decade, in aviation, human factors training has
become mandatory. The skills are assessable and mandated by the
regulator. Any pilot unable to demonstrate the skills will have his
license revoked.
7. In our recent research we have delivered human factors training
courses to the surgical teams. The content and style of the courses
are based on evidence from other safety related industries but
tailored to the healthcare professionals' needs. Subjects covered
include: Leadership, Team-working, Communication,
Cognitive Awareness and Decision Making skills.
9. Research indicates that one of the most effective methods of
making teams safer and more efficient is by having a briefing prior
to embarking on a task, particularly a complex and safety-critical
one. The briefing is an opportunity to plan for the expected and to
prepare for the unexpected. Research also indicates that a post
task debriefing is essential to allow team members to learn from
the event. Both briefing and debriefing are skills that need to be
understood and practiced
.
10. Changing culture is a challenge in any industry and in an
organisation the size of the NHS that challenge is even greater. It
is imperative to have a well-considered programme to train all
133 Chapter 4 While You Were Sleeping: Making Surgery Safer, DoH July 2008
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Healthcare professionals so they understand the importance of the
human condition and how that condition can affect patient safety.
Once that training is in place the next step is to regulate the
organisation so that demonstration of these skills is no longer
optional.
RECOMMENDATIONS
- We believe that training of non-technical (teamworking) skills
should be introduced immediately at all stages of medical
education and across all disciplines.
- There are many NHS staff who recognise the problems and are
capable of suggesting solutions. They should be encouraged to
develop these solutions which would fit the culture prevalent within
their own Trust.
- Independent investigation of unsafe occurrences must be
mandated to avoid protectionism.
A2.5 From a Memorandum by the Health and Safety Executive
(HSE) .
“EXECUTIVE SUMMARY:
1. The Health and Safety Executive (HSE) has a wide-ranging
statutory role to regulate risks from work activities, this includes
………risks to patient safety. HSE has taken formal enforcement
action including prosecution of NHS Trusts for failing to prevent
or adequately control patient safety risk in a number of areas. The
interaction between our regulatory regime and that of other
inspection bodies and regulators in the health services area is not
always clear.
2. In accordance with the Government's Enforcement Concordat,
and Hampton principles for better regulation, HSE seeks to ensure
its action is effectively co-ordinated with other healthcare
regulators to minimise overlap. However, although HSE may agree
to defer to others considered more appropriate to act in certain
areas, HSE is on occasions drawn into investigating patient safety
matters as "the enforcer of last resort" because those other bodies
do not have appropriate enforcement powers or sanctions. This
tendency has become more marked with increasing public
expectation for public bodies to be held to account and potentially
prosecuted before the courts. The recent corporate manslaughter
legislation may also result in further HSE involvement in
supporting police-led investigations. There are resource
implications for HSE in this.
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3. The current situation can lead to confusion for duty holders,
inhibit the establishment of improved management practices and is
not necessarily the most effective use of public resources. It is
hoped that the establishment of the new Care Quality Commission
and its associated provision of enforcement powers can be used to
ensure more effective regulation of patient safety.
PATIENT SAFETY AND THE ROLE OF HSE:
4. HSE is responsible for health and safety regulation in
England,…… and was established by the Health and Safety at
Work etc Act 1974 (HSWA) which is a criminal statute. HSWA
places duties on employers, the self-employed, directors,
managers, those in control of premises, and individual employees
to protect people at work and specifically to protect others (eg
patients) who may be affected by those work activities
5. Currently HSE alone has health and safety enforcement
responsibilities under HSWA for patient safety at NHS premises.
To seek compliance with the law, HSE inspectors have powers
under HSWA including prosecution and the serving of statutory
prohibition and improvement notices. Alongside this, HSE uses a
range of other tools to promote improved safety standards,
including the provision of verbal and written information and
advice, publication of guidance and liaison with the many
healthcare stakeholders.
6. HSE is committed to improving patient safety and works
actively to support the Concordat of health service regulatory and
inspecting bodies. To this end HSE has worked closely to influence
the standards produced by bodies such as the Healthcare
Commission and the NHS Litigation Authority, and has agreed
Memoranda of Understanding with, for example, the General
Medical Council and the NHS Security Management Service.
Indeed HSE is uniquely positioned to help improve standards of
patient safety as it is the only independent regulator with the
powers to bring NHS Trusts failing in their legal responsibilities
before the Courts.
7. The scope of HSWA to protect people such as patients who
may be put at risk by work activities is very broad and
consequently raises issues of both competence and availability of
resources. Given this, HSE's policy from the 1980s was that we did
not apply HSWA to patient care issues, as these fell to the
Department of Health, its agencies, and the professional
regulatory bodies such as the General Medical Council. However,
subsequent legal advice confirmed that, in the absence of a health
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services body with equivalent enforcement powers to HSE (that is,
access to criminal sanctions), this policy could be subject to
challenge. We therefore changed our enforcement policy in the
mid-1990s and have, for some years, applied health and safety
legislation to many aspects of patient safety. The only exception to
this is clinical decisions about diagnosis or treatment. The
background to this policy and its implications are covered in more
detail in Annex 1. Annex 2 includes examples of specific cases
where HSE has taken action against NHS Trusts for patient safety
incidents.”
“12. This overlap of legislation and policies can serve to confuse
dutyholders, eg an NHS Trust, whose general standards of clinical
governance and adequacy of patient service delivery are inspected
by one body (Healthcare Commission), but whose failures may be
investigated and potentially subject to criminal sanctions by HSE
and / or the police. There can also be difficulties in ensuring that
the lessons learnt from a variety of investigations are taken
forward in a coordinated way which does not leave patient safety
at risk.”
A2.6 From a Memorandum by the Medical Protection Society
“KEY RECOMMENDATIONS
3. A formal collaborative framework of bodies with interests
central to patient safety should be established. This structure
would act as a repository for lessons learned and from which best
practice could be disseminated.
4. National research should be commissioned to examine to what
extent risk management interventions are successful and cost
effective in reducing the impact of adverse incidents.
5. Patient safety and risk management should be embedded within
the undergraduate and postgraduate curricula. Hospital induction
programmes should be mandatory for all new healthcare staff.
They should be consistent and comprehensive in content and
quality and should include training in clinical governance and risk
management.”
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A2.7 From a Memorandum by the Confidential Enquiry into Maternal
and Child Health (CEMACH)
“EXECUTIVE SUMMARY
Introduction
1. The national confidential enquiries are part of the overall
system for improving patient safety. The conclusions of the
evidence provided in this submission are:
— The role of national confidential enquiries could be more
closely integrated with the rest of the system for improving
patient safety.
— Specifically, they could be used to independently assess
whether the high standards of clinical care promulgated in
national clinical guidelines are applied locally.
— Further, higher priority should be attached to the new
national confidential enquiry into child health.
Role of National Confidential Enquiries
2. There are three national confidential enquiries funded by the
Department of Health and commissioned by the National Patient
Safety Agency (NPSA). These are the National Confidential
Enquiry into Patient Outcomes and Deaths (NCEPOD), the
National Confidential Inquiry into Suicides and Homicides
(NCISH) and the National Confidential Enquiry into Maternal and
Child Health (CEMACH). These organisations provide a blamefree environment in which the quality of care provided to
individual patients with adverse outcomes is reviewed by
independent clinicians. The origins of national confidential enquiry
go back to the 1950s. They make a unique contribution to
improving patient safety.
3. CEMACH identifies avoidable factors by assessing against
recognised standards the care provided to the pregnant mother, the
unborn and newborn baby, and children up to the age of 18.
Information is aggregated from many cases to produce systemwide learning. The approach has achieved many improvements in
patient care over the years and is highly respected by practising
clinicians.
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4. The standards used by CEMACH to assess the quality of care
provided come from authoritative bodies such as the medical royal
colleges. Increasingly the source of the standards we use is the
clinical guidance being issued by the National Institute for Health
and Clinical Excellence (NICE).
Scope for developing national enquiry role in improvement of
patient safety
5. Confidential enquiries could be more closely integrated with
the wider system for improving patient safety. They are uniquely
well placed to be used to provide an independent assessment of the
effectiveness—in terms of influencing local clinical practice—of
the national investment in the growing body of clinical guidance,
including that issued by NICE.
6. The need for the development of such a role is a natural
extension of the reforms introduced in the late 1990s. These
reforms were intended to ensure consistently high standards of
health care provision. They included the establishment of the
Healthcare Commission (HCC), the NPSA and NICE. NICE fulfils
an important role in drawing up national clinical guidelines
containing standards for high quality care. The independent
assessment of whether these high standards are applied in practice
is less well-developed. National confidential enquiry could provide
an efficient and effective mechanism for filling this gap.
Greater priority for the national enquiry into child health
7. Confidential enquiries into child health are new, having
started in 2004. In the first ever national confidential enquiry
report on children, published in May 2008, we found avoidable
factors in 26% of child deaths. The deaths often occurred in
complex circumstances involving both repeated individual
clinician error and systemic shortcomings. Current expenditure on
the national enquiry into child health is some £300,000 a year.
This relatively modest sum limits the amount of work that can be
done in this very important area.
8. We believe that within the overall national confidential
enquiry programme, higher priority should be given to work on
developing a greater understanding of avoidable factors in adverse
outcomes for children, including death. The confidential enquiry
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approach could provide a cost effective way of improving the
safety of health care provided to children.
A2.8 Memorandum by the Patient Liaison Group: Royal College of
Surgeons England
“EXECUTIVE SUMMARY
We have tried to raise questions and highlight concerns around
the questions you pose in this inquiry. Many of our concerns are
about the possible implications of decisions taken at both national
and local level, which may have unforeseen implications for the
quality of patient care and safety.
We have particular concerns about the impact of national policy,
targets and Working Time Directive compliance on how care is
delivered.
At a time when the boundaries between health professionals are
rapidly blurring, we feel that patients and the public need to be far
better informed about who is delivering their care and how that
care is delivered. They need to be told about changes made and
reassured that those changes in service delivery are based on real
clinical rationales, not driven by economics alone, and are not
going to endanger the quality or safety of their care. Only if
patients are well informed, and their views respected, will they
have real confidence in the service. Patients should be able to
provide their own assessment of patient safety issues based on a
good understanding of how the service works, rather than having
to rely on learning about it from press headlines.
There may be many useful lessons that could be learned from the
experience and training carried out in other high-risk industries
such as the airlines and applied within surgery for example.
There is a need to change the culture to one where reflection on
practice is used to enhance learning and skills, rather than
encourage "blame".”
A2.9 Memorandum by the Quality, Reliability, Safety and Teamwork
Unit, Oxford University (QRSTU)
1. EXECUTIVE SUMMARY
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1.1. There is conclusive evidence that modern hospital care
carries a high risk of harm to patients.
1.2. QRSTU write as a group of researchers concerned to
discover the truth about how harm due to healthcare comes about,
and how it can be prevented. Our particular focus is on surgery,
but we believe the relevant principles are common to all hospital
disciplines.
1.3. Analysis of the causes of patient harm supports a model in
which defects in (a) staff communication culture, (b) systems of
work and (c) technology can combine unpredictably to cause harm.
1.4. We wish to submit some evidence from our work about
methods which appear effective in reducing error and improving
compliance with best practice in surgery.
1.5. We wish to report the experiences gathered during these
studies, and the insights they gave into the reasons for resistance
and failure in introducing safety interventions in healthcare
systems.
1.6. We are concerned that the evidence base on which
recommendations are likely to be made is currently very weak, and
would submit that regulation, training and the imposition of
mandatory systems for harm reduction should be based on sound
scientific data.
1.7. We recommend an urgent increase in the amount of research
effort devoted to this problem, so that innovation can proceed with
confidence.
1.8. We recognise the need for urgent action to improve the
current situation, and do not wish to suggest that action should be
deferred until conclusive research findings are available. We
suggest instead that certain broad safety principles, already
capable of being enunciated and supported from current evidence
in healthcare and other industries, should be strongly supported,
and that mandatory systems and regulation should be avoided
except where sound evidence is available.
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1.9. We recognise that current clinical governance systems are
largely ineffective, and recommend that they are re-structured
according to the principles referred to above.
A2.10 From a Memorandum by the National Patient Safety Agency
(NPSA)
“EXECUTIVE SUMMARY
4. The NPSA asks the committee to consider the following
recommendations:
— Boards, senior managers and senior clinicians need to
demonstrate that patient safety is their top priority
— All NHS organisations should have robust systems for reporting
incidents locally and nationally. Importantly these should lead to
learning and action. The response system is always more important
than the reporting system
— All NHS organisations should have local strategies to ensure
quicker implementation of safer practices where important risks
have been identified
— The new regulator, the Care Quality Commission, should
maintain and build the focus on patient safety achieved by the
Healthcare Commission
— Every primary care trust commissioner should make patient
safety a key aim of commissioning
INTRODUCTION
7. The top ten risks to patient safety are:
— Variable leadership from Boards, senior clinicians and senior
managers
— A blame culture which drives problems underground
— Defensive communication with patients and their families when
things go wrong
— Limited patient safety education for staff in their basic training
— Not enough emphasis on building high performing frontline
teams
— A reactive approach to risk meaning that hazards are not
identified before they lead to patient harm
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— A superficial approach to incident investigation which often
fails to identify the underlying causes and system weaknesses
— Inadequate standardisation of equipment and processes
causing unsafe variability
— Patchy and slow implementation of safer practices in frontline
services
— Not harnessing technology as a powerful tool for protecting
patients against harm
A2.11 From a Memorandum by the Medical Defence Union
“EXECUTIVE SUMMARY:
— We recommend that members of the secondary and primary
care teams take part in regular systematic significant event audit
and that the results are collated regionally and on a national basis,
to identify potential risks to patient safety. Such information can be
shared with managers and clinicians to assist them to improve
patient safety.
— We recommend that complaints and claims data is pooled
across the UK. Details of the complaints and claims analysed and
risk management advice should be shared regularly with managers
and clinicians to assist them to make decisions and to inform their
practice.”
A2.12 From a Memorandum by the Royal College of Nursing
EXECUTIVE SUMMARY
1.1 Clinical practice can never be risk-free, human error and poor
judgement will always contribute to patient safety risks.
1.2 However risk is not simply created by individuals. It is most
important to acknowledge the role of the context in which care is
delivered and the impact this has on individuals' performance and
capacity to deliver safe care.
1.3 Focus on specific issues such as key Healthcare Associated
Infections (HCAIs) has been beneficial in bringing about some change
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and improvement. However there is some concern that publicity
surrounding hospital acquired infections may distract from other
important patient safety issues.
1.4 A particular concern for patient safety is when there are "broken
processes" in the health care system, for example: failure to
communicate appointments; loss of records; patients with comorbidity being treated by different parts of the service acting in
isolation; inequality of access to specialist services; and failure to
manage and provide appropriately skilled staff.
1.5 Technology must meet the highest requirements for usability in
the care setting, and staff and patients require appropriate skills to
use it safely and effectively.
1.6 Not enough is known about the impact of poor "health literacy"
and its implications for patient safety.
1.7 Clearly the main driver for better patient safety in all settings
will be the new Care Quality Commission. The RCN has consistently
made the point that regulation of health and social care needs to be
adequately funded.
1.8 Patient safety initiatives must be linked with the Human
Resources Framework. We believe that a failure to implement
effective HR systems can impact on patient safety.
1.9 There is a professional responsibility to report incidents and
near misses, and nurses are among the best professional groups in
terms of reporting patient safety incidents. The blame culture still
exists in some environments and this may contribute to under
reporting of staff or patient related incidents.
1.9.1 The RCN feels that education and training of staff is an
important component in contributing to the management of risk. There
is a real need to support staff to increase their understanding of
patient safety and devise ways of maintaining their knowledge and
skills over the course of their working lives.”
A2.13 From a Memorandum by the Royal College of Midwives
“EXECUTIVE SUMMARY
1.3 The best way to improve safety from where we are now is to
investigate what goes wrong and attempt to stop such things
happening again. The structures are in place to do this on a
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systematic and ongoing basis, through such routes as the
CEMACH investigations.
1.4 Good work like this is being done, but the findings are not
always implemented. We believe that this is because local services
are distracted by the demands of the centre to deliver on
politically-important targets. This means that maternity care loses
out because there is no sanction for a service which does not
implement policies in the area. As babies do not wait, there can be
no waiting list for birth.
1.5 Additionally, maternity services suffer because of the split
between acute and community care—much maternity care is
delivered in the community and loses out to the demands of the
acute sector. To turn this around, we need to see the extra
resources, both in terms of midwives and investment.
1.6 We recommend midwifery representation on Trust Boards so
that issues of safety in maternity care can be raised at the highest
local level.
1.7 Finally, we must see vast improvements in the collection of
data. The current situation is very patchy. The Committee has
raised this before; it should raise it again.”
A2.14 From a Memorandum by Action against Medical Accidents
“EXECUTIVE SUMMARY
— urgent action to implement recommendation 12 of Safety
First[344] to make "Being Open"[345] a reality (see paragraph
4.4),
— consolidation of the National Patient Safety Agency (NPSA) as
the key central organisation focussed purely on patient safety, and
more "clout" to be given to its alerts / guidance,
— more priority/resources being deployed to safety "solution" or
intervention work on known issues rather than making
reporting systems more elaborate,……….”
A2.15 From a Memorandum by the Royal College of Pathologists
The single greatest improvement in patient safety in the area of
laboratory medicine would be the implementation of hospital-wide
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(or UK-wide?) automatic identification systems (ie IT-linked
barcodes and/or RFID devices), applicable to patients, medicines,
procedures and investigations including radiology and laboratory
investigations. Many commercial organisations have implemented
systems of this sort, including all major retail chains and London
Transport (ie. the "Oyster card" system). Why not the NHS?
A2.16 From a Memorandum by the Royal College of Anaesthetists
21. A Safe Anaesthesia Liaison Group is in the process of being
established which will comprise core membership from the RCoA,
NPSA and AAGBI. This group will be administered by the RCoA
and will produce and disseminate regular reports on safety issues
in anaesthesia based on incident data and also make
recommendations for future safety improvement initiatives and the
need for further research if applicable.
22. This specialty reporting initiative now provides the NPSA with
the opportunity to meet the requirements of the RCoA and also to
develop a template for specialty-based reporting which may be
transferable to other specialties in the NHS; a key example would
be obstetrics and gynaecology. The system development has
included the following key success-targeted principles:
— a user friendly approach
— a specialty-specific focus
— sensitivity to the confidentiality of the reporter
— it is complementary to the local reporting systems of the
hospitals
— it is responsive—ie each reported incident should generate an
appropriate response intended to improve patient safety.
A2.17 From a Memorandum by the Council for Healthcare Regulatory
Excellence
“PATIENT SAFETY AND HEALTH PROFESSIONS
REGULATION
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3. The purpose of the regulation of health professions is to
protect the public and enhance public trust. The regulation of
health professions therefore has a very important role to play in
relation to patient safety. The work of the individual regulators in
setting standards for health professionals, maintaining a register of
professionals, taking action where a professional's fitness to
practise has been called into question, and in assuring the quality
of education and training is all focused on public protection and
patient safety. The regulators address particular risks to patient
safety by for example:
— Restricting the practice of professionals whose fitness to
practise is impaired
— Taking action to ensure that untrained/unqualified individuals
do not practice as a health professional
— Promoting standards of conduct and competence to all
registered professionals”
A2.18 From a Memorandum by the NHS Confederation
The NHS Confederation is the only independent membership body
for the full range of organisations that make up today's NHS. We
represent over 95% of NHS organisations. We have a number of
Networks which represent sector-specific services including
Foundation Trust Network, Primary Care Network, Mental Health
Network, Ambulance Services Network and the NHS Partners
Network, which represents independent (commercial and not-forprofit) healthcare providers of NHS care.
NHS CONFEDERATION KEY POINTS
…
— Error cannot be eliminated and therefore the emphasis should
be on minimising the incidence and impact of harm.
— A systemic approach to preventing, analysing and learning
from errors is essential to embed changes for patient safety.
— Identifying risks, learning and feedback need to be underpinned
by a "fair" blame culture
— Leadership from the top is essential for promoting safety
cultures.
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— There is more to be done to encourage reporting from GPs.
— The wider system, including regulators, has a role to promote
high reporting of patient safety incidents as good news.
— The Care Quality Commission must take ownership of the
quality and safety agenda, and lead a co-ordinated approach to
ensuring patient safety.
— The role of commissioners in improving safety needs to be
clarified.
— There is more to done to engage patients in improving safety.
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A note about the Authors
Simon John
Simon has practised as a solicitor in East Anglia since 1969, and for
many years until taking a consultancy was the senior partner of one of the
largest firms in the region.
Until his recent retirement he was a Fellow of the Society for Advanced
Legal Studies and a Senior Fellow of The Association of Personal Injury
Lawyers.
He is a founding member of The Forum of Complex Injury Solicitors. He
was a member of The Law Society Panels of Specialist Solicitors for
personal injury and clinical negligence.
He was a member of the British Institute of International and
Comparative Law and remains a member of Advocates for International
Development. He has co-conducted clinical negligence and personal
injury litigation in and from many states in the US.
He has written and lectured widely on his specialist subject of clinical
negligence. He was the author of the predecessor paper and presented on
it by invitation to The Civil Justice Council in 2002.
He is a trustee of The Child Brain Injury Trust. Eight members of his
immediate family work or have worked in a professional capacity in the
NHS, four of them also in other countries healthcare systems.
Dr Michael J Powers QC
Michael was trained as a doctor and practised for a number of years
before going to the Bar. He retains both his registration and his licence to
practise medicine. He is a lead examiner for the Faculty of Forensic and
Legal Medicine of the Royal College of Physicians and an elected Fellow
of the FFLM.
An interest in aviation led him to obtain a helicopter private pilot’s
licence with ratings on three different types of aircraft. The approach to
safety in aviation spurred Michael to become a founder member of
CORESS which was mirrored on the effective CHIRP (Confidential
Reporting Programme for Aviation and Maritime).
Michael’s practice at the Bar over the last 30 years has been largely in
these fields of medicine and aviation. He has edited Clinical Negligence
(formerly Medical Negligence) since the 1st edition, over 20 years ago.
Besides contributing chapters to many books and writing and lecturing on
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the subject he has been instrumental in developing the concept of the
Medical Accidents Investigation Authority (MAIA) mirroring the
excellent work done by the AAIB, MAIB and the RAIB.
He has co-authored (with Dr Paul Knapman) 3 books on Coroners Law,
acted as an Assistant Deputy Coroner and is a past president of the South
East England Coroners’ Society. He has written papers, lectured and
broadcast on matters affecting coroners. He was appointed a QC in
1995, a Bencher of Lincoln’s Inn in 1998 and granted an honorary LLD
by the University of Plymouth in 2010.
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